Nasal Dilator and Methods of Fabricating Medical Devices

ABSTRACT

A nasal dilator comprises adjacent, substantially parallel resilient members having mid-sections substantially parallel to the dilator longitudinal centerline and end portions that diverge obliquely away from the centerline. The dilator may comprise a laminate of vertically stacked material layers that each have a different peripheral shape, and greater or lesser surface area, from that of the others. The dilator may comprise resilient members that diverge or curve symmetrically about the dilator longitudinal centerline such that a shape of a resilient member on one side of a lateral centerline is a mirror image of its shape on the opposite side of the lateral centerline.

RELATED APPLICATIONS

This application is a Continuation of U.S. Non-Provisional patentapplication Ser. No. 15/817,525 filed 20 Nov. 2017, which was aContinuation of U.S. Non-Provisional patent application Ser. No.14/139,619 filed 23 Dec. 2013, now U.S. Pat. No. 9,844,456, which was aContinuation of U. S. Non-Provisional patent application Ser. No.12/964,746 filed 10 Dec. 2010, now U.S. Pat. No. 8,641,852.

FIELD OF THE INVENTION

The present invention relates generally to converting elongated materialwebs into finished parts or devices such as may be used in the medical,high-technology, electronics, automotive or aerospace industries. Themethods are particularly suited to the converting of elongated sheets orrolls of thin flexible materials such as papers, films, foils, tapes,synthetic fabrics and the like, including those having an adhesivesubstance disposed thereon, into mass produced medical devices such aselectrodes, transdermal devices, wound care dressings and closures, etc.The present invention specifically relates to apparatus and methods ofdilating external tissue in humans, including methods of fabricatingtissue dilator devices. As disclosed and taught in the preferredembodiments, the tissue dilator devices and methods of fabricatingmedical devices and tissue dilators are particularly suitable for, andare directed primarily to, external nasal dilators for supporting,stabilizing, and dilating nasal outer wall tissues adjacent andoverlying nasal airway passages of the human nose, including the nasalvalve and the nasal vestibule areas thereof. The United States Food andDrug Administration classifies the external nasal dilator as a Class IMedical Device.

BACKGROUND OF THE INVENTION

A portion of the human population has some malformation of the nasalpassages which interferes with breathing, including deviated septa,swelling due to infection or allergic reactions, or inflammation due tochanges in atmospheric humidity. A portion of the interior nasal passagewall may draw in during inhalation to substantially block the flow ofair. Blockage of the nasal passages as a result of malformation,symptoms of the common cold or seasonal allergies are particularlyuncomfortable at night, and can lead to sleep disturbances,irregularities and general discomfort.

In use the external nasal dilator is flexed across the bridge of thenose, extending over the nasal passage outer wall tissues on each sideof the bridge, and held thereto by an adhesive. A resilient member (alsoreferred to as a spring member, resilient band, or spring band) isembedded in, or affixed to, the device. The resilient member may bebisected lengthwise into two closely parallel members. Flexure createsspring biasing forces in the resilient member, extending from the middleto the opposite end regions of the device, pulling outwardly to dilateor otherwise stabilize the outer wall tissues of the nasal airwaypassages. This decreases airflow resistance within the nasal passagesand produces a corresponding ease or improvement in nasal breathing.

The resilient member typically produces between 15 grams and 35 grams ofresiliency or spring biasing force. Constructing a nasal dilator withless than 15 grams of spring biasing force may not provide suitablestabilization or dilation, while greater than 35 grams would beuncomfortable for most users. Using a more aggressive adhesive, agreater amount of adhesive, or greater adhesive surface area so as towithstand greater spring biasing increases the likelihood of damage tothe tissue upon removal of the device.

Examples of present external nasal dilators are disclosed in U.S. Pat.Nos. 6,453,901, D379513, D429332, D430295, D432652, D434146, D437641 andU.S. patent applications Ser. Nos. 08/855103, 12/024763, 12/106289, and12/402214, the entire disclosures of which are incorporated by referenceherein. A minority of the external nasal dilator prior art is adaptablefor mass production and thus commercialization in the present consumerretail market. Examples of commercialized nasal dilators, knowcollectively as nasal strips, include devices disclosed in U.S. Pat.Nos. D379513, 6,453,901, 5,533,503, 5,546,929, RE35408, 7,114,495 andcertain devices based upon Spanish Utility Model 289-561 for OrthopaedicAdhesive.

While these example devices provide dilation or stabilization to nasalouter wall tissues in a majority of users, there is a need in the artboth to provide variety and complexity in commercially feasible dilatordevices and to overcome certain inherent limitations of nasal dilation,including: limited skin surface area adjacent the nasal passages toengage a dilator device; a limited range of spring biasing force that isboth effective and comfortable; the dynamic relationship betweenadhesive engagement and spring biasing peel forces as affects efficacy,comfort and engagement duration; and economically producing complexdilator devices on a mass scale. The present invention discloses noveldilator devices and methods of manufacturing dilator devices whichaddress unmet needs in the art and the limitations of nasal dilation.

A particular inherent limitation of the external nasal dilator is thatspring biasing creates peel forces at its opposite end regions, togetherwith some tensile forces, which act to disengage the device from theskin surface. Dilator devices disclosed in U.S. Patent Nos. 5,533,503and 6,453,901, and U.S. patent application Ser. No. 12/106289 includedesign attributes to mitigate the effect of peel forces or to otherwiseshift at least a portion of peel forces into sheer forces. Accordingly,a dynamic relationship exists between dilator design, its flexed springbiasing force, and its efficacy. The present invention builds upon theprior art to address this relationship and further enhance dilatorfunction and comfort.

Nasal dilator devices in the prior art are typically symmetric on eachside of the device centerline, which is aligned to the centerline of thebridge of the nose. Each half of the dilator on each side of thecenterline is the mirror image of the other. Similarly, each long halfof the device, bisected along its length, is typically the mirror imageof the other. However, symmetry has not been generally incorporated intodilator design so as to gain manufacturing economy. Of limited exceptionis where a plurality of dilator devices are die cut on common linescorresponding to their long edges. However, this technique isfacilitated by the device having a constant width along its length; adilator design having wider end regions and a narrower mid section isgenerally more comfortable and more effective. The present inventiondiscloses novel means of using symmetry in medical device design, andincorporates symmetry into methods of manufacturing dilator devices oncommon longitudinal lines.

There has also been a continuing need in the art to develop efficientways of fabricating complex nasal dilator resilient members andincorporating them into mass produced nasal dilators. Complex resilientmembers are disclosed in the prior art, but not generally practiced incommercially available nasal strip products. For example, FIGS. 12, 17,20 and 22 of U.S. Pat. No. 6,453,901 illustrate complex resilient memberstructures in dilator devices, including a method (illustrated in FIG.16) of forming continuous interconnected resilient members. However, asignificant quantity of material extending around and between theinterconnected resilient members is lost. The preferred and commonlyused material from which resilient members are fabricated carries asignificantly greater cost per unit of measure than other materials usedin the device. Accordingly, simple resilient member structures prevailin commercialized dilator devices. The present invention discloses meansby which to economically mass produce complex resilient memberstructures with a material usage-to-waste ratio consistent with thefabrication of simpler structures.

The total cost of a medical device is generally the sum of the cost tomanufacture (or convert) the device plus the cost of the material used.Material cost includes that which goes into the finished device plusthat which is wasted in the converting process. A dynamic relationshipexists between converting cost (setup, calibration, registration andalignment, material handling and fabrication time), and material cost;manufacturers (or converters) often obtain efficiency in one area at theexpense of the other. Medical devices are typically die cut incookie-cutter fashion to reduce converting time, but at the expense ofmaterial waste extending around and between finished parts. The presentinvention discloses various methods to reduce material waste whileminimizing any additional converting time.

A common practice is to fabricate external nasal dilators having amaterial layer above as well as below the resilient member. The twolayers are die cut simultaneously, largely to shorten converting time.Thus each material layer comprises about 1.66 square inches of material(based on average overall device dimensions of about 2.63″L×0.63″W), fora total of about 3.31 square inches of material per device. The presentinvention discloses means to reduce material in at least one of thelayers with only a modest increase in corresponding converting time.

Similarly, nasal dilator resilient members are traditionally formed froma continuous strand of material equal to each member's finished width. Aplurality of strands are slit along common long edges, then separatedand repositioned laterally across the fabrication matrix. Repositioningmay constitute a separate and additional converting operation, whichcarries a cost. The present invention discloses means whereby to slitand position strands in the converting process simultaneously, without aseparate and additional operation. The present invention furtherdiscloses means to re-incorporate potentially unavoidable resilientmember material waste into a subsequent fabrication process which yieldsadditional or complementary dilator devices.

Where a nasal dilator resilient member is fabricated to be centeredwithin the peripheral edges of the finished device, material waste canbe up to 73%. This manufacturing technique (called island placement)simultaneously die cuts and registers a plurality of spaced apartcomponents along a material strip, or across and along a material web,so that each component (i.e., the resilient member) is centered withinthe perimeter edges of another plurality of similarly registeredcomponents (material layers which form the rest of the dilator). Islandplacement requires additional material extending along each side of thefinished resilient member plus material extending between successivedevices fabricated lengthwise end to end. The additional material isused as a matrix by which to space the finished resilient members apart;the wider the matrix, the poorer the usage-to-waste ratio. Once theresilient members are die cut, the matrix is removed as a whole fromaround and between the spaced apart resilient members and discarded asnecessary waste.

By example, a finished resilient member may be about 2.25″ long×about0.24″ wide, for a total of 0.54 square inches of material. Whereresilient members are formed from a continuous strip of material, adding0.125″ to each long edge of the strip increases strip width to 0.49″.Individual resilient members must also be spaced apart lengthwise byabout 3″ from center to center to allow adequate perimeter space to forma finished dilator device being about 2.63″ long. This means 1.47″ sq.(3″×0.49″) of material is used to fabricate and position a resilientmember comprising 0.54″ sq. of material. The resulting usage-to-wasteratio is nearly 1:4, where about 27% of the material is used for thefinished resilient member and about 73% of the material is wasted. Thepresent invention discloses means to improve resilient member materialwaste, particularly in the fabrication of complex resilient memberstructures, where the higher per unit material cost has the greatestimpact on manufacturing economy.

Similar to the fabrication of island-placed components, finished nasalstrip devices are typically manufactured in a continuous process whichspaces one device from another by about 0.125″ on all sides so thatmaterial not devoted to the device itself (the waste matrix) can beremoved as a whole. Finished devices meant to be packaged in the sameoperation are spaced even farther apart to provide a suitable contactperimeter around each unit so that upper and lower packaging materialwebs may form an adequate seal. Again, material from which finisheddevices or device elements are fabricated is often used as the matrix bywhich to space finished devices apart. Nasal strips fabricated in closerproximity to each other in order to avoid that material waste are oftenpackaged in a separate, dedicated operation, thus incurring acorresponding cost. The present invention discloses means to fabricatemedical devices so as to reduce waste, and to simultaneously spacefinished devices apart so as to seal the devices between packaging webs,without incurring a separate operational cost or the traditional amountof material waste.

SUMMARY OF THE INVENTION

The present invention discloses methods for converting elongatedmaterial webs. The methods are particularly suited to mass producingmedical devices, particularly the external nasal dilator. Methods aredetermined in part by device design and device design is shaped bymethods so as to create efficiencies and extend material yield. Whilethe manufacturing methods of the present invention are suitable oradaptable to a range of converting applications, and particularly tomedical devices, the preferred embodiments are primarily directed toproducing complex external nasal dilator devices economically on a massscale.

Manufacturing methods of the present invention revolve around formingcontinuous slits in an elongated flexible material web. The slits alterthe material web into a plurality of adjacent, or laterally contiguous,elongated strands. The strands are separated from the material web andcombined with at least one additional material web in a continuousprocess which forms a material laminate. The strands may also becombined with other strands slit from a different material web and thencombined with another material web to form a material laminate. Thematerial laminate may be die cut into finished devices or it may be slitinto laminate strands which are subsequently die cut into finisheddevices. Laminate strands may also be combined with another material weband then die cut into finished devices. The material laminate orlaminate strands may be combined with upper and lower packaging materialwebs so as die cut and package the finished devices concurrently.

An elongated flexible material web generally consists of a singlematerial layer with an adhesive substance disposed on one surface and aprotective paper liner releasably secured to the adhesive. A materialweb may also comprise more than one material layer. The continuous slitsextend vertically through at least a portion of the elongated materialweb and longitudinally along, or generally consistent with, the machinedirection of the web without intersecting the outside long edges or anadjacent slit. Otherwise the slits may be straight or may havedivergent, angled or curved segments. The slits may be parallel to eachother or may diverge laterally from one another. Two adjacent slitsdefine a strand, and the strand may thus be straight, divergent, have agradient width or a varying width.

An elongated strand or laminate strand consists of a plurality ofinterconnected objects integrated into the strand. The objectscorrespond to an element, layer, member or component of a medicaldevice. Accordingly, the continuous slits follow criteria determined bythe design of the object and the design of the medical device to whichthe object is a part. That criteria includes: forming the object todimensions appropriate to the element, layer, member, component orfinished device; defining at least a portion of the peripheraldimensions of the object or finished device; pre-positioning or aligningobjects to each other or to a registration point where the finisheddevice will be die cut; and creating a predetermined lateral spacingbetween strands, and ultimately objects, as the strands are separatedfrom a material web and combined into a material laminate. Predeterminedspacing is a function of strand width and/or the collective width of agroup of strands.

Since a strand or laminate strand consists of a plurality ofinterconnected objects, then each continuous slit in an elongated web ormaterial laminate thus forms, as well as defines, at least a portion ofone long edge of two objects adjacent each other (one to each side ofthe slit). At least portions of these long edges of adjacent objects orfinished devices are thus formed on common lines. Again, theinterconnected objects correspond to an element, layer, member orcomponent of a medical device, or the device itself.

The interconnected objects of a strand or laminate strand are completedby severing, such as by cross slits extending between the long edges ofa strand or laminate strand, or by die cut lines contained at least inpart within the width of a strand or laminate strand, or by enclosed diecut lines formed in a material laminate or laminate strand. Die cutlines generally form finished or semi-finished devices in a materiallaminate or laminate strand, but die cut lines may also form, in wholeor in part, elements, layers, members, or components of a finisheddevice in a material web, a strand, or some combination of material websand elongated strands.

One purpose of forming and combining strands and material webs intomaterial laminates and laminate strands is to eliminate material wasteand extend material yield without increasing converting time to thepoint of offsetting savings gained. Particularly effective is formingstrands of the most expensive materials, then separating or dividingthese strands into multiple material laminates consisting of lessexpensive materials.

Forming strands in a material web and dividing them into multiplelaminates is also an effective alternative to using the web as a matrixby which to space apart a plurality of components to be die cuttherefrom.

The present invention discloses means for separating strands from amaterial web without having to reposition them in a separate, dedicatedoperation. Continuous slits form a plurality of adjacent, or laterallycontiguous, strands in a material web such that the plurality consistsof consecutive, or adjacent, groups of strands. One or more selectstrands is separated from each group (e.g., every other, everyone-in-three, every two-in-eight, etc.) such that the separated strandsare laterally spaced apart, and thus pre-positioned, or registered, whencombined with other material webs. The individual widths of theseparated strands and the collective width of one or more of theconsecutive groups of strands defines the spacing between the separatedstrands. That spacing, together with strand width, corresponds todimensions and other design attributes of finished devices or theobjects which make up finished devices.

The present invention further teaches, depicts, enables, illustrates,describes and claims new, useful, and non-obvious apparatus for dilatingexternal tissue. The present invention builds upon the prior art andaddresses unmet needs in the art. The nasal dilator of the presentinvention comprises an engagement element, a functional element, and adirectional element. The functional element of the dilator comprisesresilient means including at least one resilient member extending alongits length and which provides the spring biasing force of the device. Inuse, the engagement element affixes the dilator to the nose of a userthrough engagement means. The directional element affects, alters,directs or redirects the spring biasing properties of the dilator so asto increase its overall efficacy, useful duration, comfort, and ease ofuse.

Nasal dilators of the present invention comprise a laminate ofvertically stacked material layers which form the dilator as a unitary,single body truss. Dilator layers are formed in whole or part fromelongated material webs, elongated strands, material laminates orlaminate strands. Dilator layers are preferably secured to one anotherby an adhesive substance disposed on at least portions of at least oneflat surface side of at least one layer, and the resulting laminateforms a unitary, or single body, truss. Each layer includes one or moremembers, and a member may further include one or more components. Eachof the engagement, functional, and directional elements is defined by atleast a portion of at least one layer of the device.

The single body truss comprises horizontal regions, including first andsecond end regions adapted to engage outer wall tissues of first andsecond nasal passages, respectively, and an intermediate region adaptedto traverse a portion of a nose located between the first and secondnasal passages and joining the end regions. The truss is capable ofresilient deformation such that when flexed it returns substantially toits pre-flexed state. In use the dilator stabilizes nasal outer walltissues, and may further expand or dilate the nasal outer walls toprevent tissues thereof from drawing inward during breathing. The trussis configured to be comfortable on the skin surfaces engaged and to beeasily removed with little or no stress thereto.

It is the principal objective of the present invention to provide novelmethods of converting elongated flexible material webs so as to reducemanufacturing cost, to return a greater number of finished devices orparts thereof per a given quantity of material and to minimize thepercentage of material discarded as waste. A more specific objective ofthe present invention is to fabricate at least portions of finishedmedical devices or portions thereof on common longitudinal lines in acontinuous repeating process. A further objective of the presentinvention is to provide novel nasal dilator devices having complexfunctional element structures, manufactured using novel, and non-obviousmethods having greater efficiency and economy than traditional methods.

It will be apparent to the skilled person in the art of medical devicedesign or converting that the manufacturing methods of the presentinvention rely on well established rotary techniques for winding,unwinding, slitting, peeling, separating, laminating, etc., and the diecutting or punching of material webs using rotary or flat-bed machinery.It is understood that fluid or pneumatic modular automation for materialfeed or handling, including components and systems, and electronic orcomputerized controls may also be applicable.

The present invention is not limited to the illustrated or describedembodiments as these are intended to assist the reader in understandingthe subject matter of the invention. The preferred embodiments areexamples of forms of the invention comprehended by that which is taught,enabled, described, illustrated and claimed herein. All structures andmethods which embody similar functionality are intended to be coveredhereby. The manufacturing methods depicted, taught, enabled anddisclosed herein, while particularly suitable for dilator devices, maybe applied to a range of medical devices. The nasal dilators depicted,taught, enabled and disclosed herein represent families of new, usefuland non-obvious devices having a variety of alternate embodiments.Dilator elements, layers, members, components, materials, or regions maybe of differing size, area, thickness, length, width or shape than thatillustrated or described while still remaining within the purview andscope of the present invention. The preferred embodiments include,without limitation, the following numbered discrete forms of theinvention, as more fully described below.

Some embodiments of the present invention are arranged in groups so asto illustrate manufacturing steps. Each group builds upon the previousby introducing a new or subsequent element, technique, or variationthereof. Accordingly, later embodiments frequently refer to, or crossreference, previous embodiments. It will be obvious to the skilledperson in the art that techniques, methods, processes, etc., may beapplied, interchanged or combined from one embodiment or group thereofto another. The width of material webs in the drawings are generallyshown only wide enough to illustrate the subject at hand. In practice,said widths may be generally greater, and in some cases lesser. Thelongitudinal extents of material webs are shown fragmentary.

For descriptive clarity, certain terms are used consistently in thespecification and claims: Vertical refers to a direction parallel tothickness, such as the thickness of a finished device, a material web,material layers, or a material laminate. Horizontal refers to the lengthof a finished device or a direction parallel thereto. Lateral refers towidth, such as that of a finished device or a material web, and to adirection parallel to the cross direction (XD) of a material web.Longitudinal refers to length, such as that of a finished device, or thelength or machine direction (MD) of a material web, or a directionperpendicular to width or lateral extent. A longitudinal centerline isconsistent with the long axis of a finished device or material web,bisecting its width midway between the long edges. A lateral centerlinebisects the long edges of a finished device or material web midway alongits length, and is perpendicular to the longitudinal centerline. Anobject or objects referred to as adjacent or consecutive anothergenerally means laterally, consistent with the width of a finisheddevice or a material web. Objects referred to as successive aregenerally oriented lengthwise, end to end, parallel to the machinedirection (MD) of a material web.

Broken or dashed lines are used in the drawings to aid in describingrelationships or circumstances with regard to objects. A dash followedby three short spaces with two short dashes therebetween indicatesseparation for illustrative purposes, such as in an exploded view, or toindicate an object or objects removed or separated from one or moreother objects for clarity, or as the result of a process or method. Aline of successive short dashes with short spaces therebetween mayindicate a hidden object, such as one underneath another; or forclarity, to illustrate a location, such as the space an object willoccupy, would occupy, or did occupy; or for illustrative purposes, toindicate an object as ‘invisible’ so that objects underneath it may beseen. A long dash followed by a short space, a short dash and anothershort space is used to call out a centerline or an angle, or to indicatealignment; when accompanied by a bracket, to call out a section, segmentor portion of an object or a group of objects, or to illustrate aspatial relationship between one or more objects or groups of objects.

In the drawings which accompany this disclosure, like objects aregenerally referred to with common reference numerals, except wherevariations of an object must be distinguished from one another. Indescribing manufacturing methods, Machine Direction is indicated in thedrawings by the letters ‘MD’ adjacent a directional arrow: a singlearrowhead indicates preferred direction; a double arrowhead indicatesflow may be in either direction. Drawings are not rendered to scale, andwhere shown, the thickness of objects is generally exaggerated forillustrative clarity.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1 is a perspective view of a portion of a face with a nasal dilatorin accordance with the present invention engaged to the nose.

FIG. 2 is an exploded perspective view of the nasal dilator of FIG. 1.

FIG. 3 is a perspective view of the nasal dilator of FIG. 2.

FIG. 4 is a plan view of a pair of the nasal dilator of FIG. 3 includingfragmentary portions of where successive dilator units may be includedtherebetween.

FIG. 5a is a fragmentary plan view of a resilient layer material webillustrating the initial step of a first form of manufacturing method inaccordance with the present invention.

FIGS. 5b-5d are fragmentary perspective views illustrating subsequentand final manufacturing steps to the first form of manufacturing method.

FIGS. 6a-6c are fragmentary perspective views illustrating alternativesteps to those of FIGS. 5b -5 d.

FIG. 7 is an exploded perspective view of a variation of the dilator ofFIGS. 1-4, produced from the alternative steps illustrated in FIGS. 6a-6 c.

FIG. 8 is a plan view of the nasal dilator of FIG. 7.

FIGS. 9a-9c are fragmentary exploded perspective views illustrating theinitial steps of a second form of manufacturing method in accordancewith the present invention.

FIGS. 9d-9e are fragmentary plan views illustrating the final steps ofthe second form of manufacturing method.

FIG. 10 is an exploded perspective view of a second form of nasaldilator embodying features of the present invention, produced from thesecond form of manufacturing method.

FIG. 11 is an exploded perspective view of a variation of the secondform of nasal dilator produced from the method of FIGS. 12 and 13.

FIG. 12 is an exploded fragmentary perspective view illustrating theinitial steps of a variation to the second form of manufacturing methodillustrated in FIGS. 9a -9 e.

FIG. 13 is a fragmentary plan view illustrating the final steps of thevariation to the second form of manufacturing method illustrated in FIG.12.

FIG. 14 is an exploded perspective view illustrating a third form ofdilator device in accordance with the present invention produced from amanufacturing method described with regard to FIGS. 15a -15 g.

FIG. 15a is a fragmentary perspective view illustrating the initialsteps of a third form of manufacturing method in accordance with thepresent invention whereby to manufacture the dilator of FIG. 14.

FIG. 15b is an exploded fragmentary perspective view illustratingintermediate steps of the third form of manufacturing method.

FIGS. 15c-15f are fragmentary plan views illustrating subsequentintermediate steps of the third form of manufacturing method.

FIG. 15g is an exploded fragmentary perspective view illustrating thefinal steps of the third form of manufacturing method.

FIG. 16 is a fragmentary plan view illustrating an overview of a fourthform of manufacturing method in accordance with the present invention.

FIG. 17a is a fragmentary plan view illustrating the initial steps ofthe fourth form of manufacturing method.

FIG. 17b-17d are fragmentary perspective views illustrating theintermediate and final steps of the fourth form of manufacturing method.

FIG. 18 is an exploded perspective view of a fourth form of nasaldilator in accordance with the present invention, produced from themethod of FIGS. 16-17 d.

FIG. 19 is a plan view of the nasal dilator of FIG. 18.

FIG. 20 is an exploded perspective view of a variation of the fourthform of nasal dilator.

FIG. 21 is a plan view of the nasal dilator of FIG. 20.

FIG. 22 is an exploded perspective view of a fifth form of nasal dilatorin accordance with the present invention, produced as complementarydevice from the method of FIGS. 23a -23 d.

FIG. 23a is a fragmentary plan view illustrating an overview of a fifthform of manufacturing method in accordance with the present invention.

FIG. 23b is an exploded fragmentary perspective view illustrating theseparation of elongated material strands into two groups as an optionalinitial step of the fifth form of manufacturing method.

FIGS. 23c-23d are exploded fragmentary perspective views illustratingthe initial steps of the fifth form of manufacturing method.

FIGS. 23e-23f are fragmentary plan views illustrating the final steps ofthe fifth form of manufacturing method.

FIG. 24a is a fragmentary plan view illustrating an alternative to theinitial steps of the fifth form of manufacturing method.

FIG. 24b is an exploded fragmentary perspective view illustratingelongated material strands from FIG. 24a separated into two groups.

FIG. 25a is a fragmentary plan view illustrating an overview of a firstvariation of the fifth form of manufacturing method.

FIG. 25b is an exploded fragmentary perspective view illustrating theseparation of elongated material strands of FIG. 25a into two groups.

FIG. 26 is a plan view of a sixth form of nasal dilator in accordancewith the present invention, produced from the method of FIGS. 25a and 25b.

FIG. 27 is a fragmentary plan view illustrating an overview of a secondvariation of the fifth form of manufacturing method.

FIG. 28 is a fragmentary plan view illustrating a relationship betweenseventh and eighth forms of nasal dilator devices in accordance with thepresent invention, produced from the manufacturing method of FIG. 27.

FIG. 29 is a fragmentary plan view illustrating a relationship betweenninth and seventh forms of nasal dilator devices in accordance with thepresent invention, produced from the manufacturing method of FIG. 27.

FIG. 30 is a fragmentary plan view illustrating an arrangement ofmaterial webs to facilitate optional steps of the second variation,shown in FIG. 27, to the fifth form of manufacturing method.

FIGS. 31a and 31b are fragmentary plan views illustrating the subsequentsteps of the optional steps begun in FIG. 30.

FIG. 32 is fragmentary plan view of a tenth form of nasal dilator inaccordance with the present invention, produced from the optional stepsdescribed with regard to FIGS. 30-31 b.

FIG. 33 is a fragmentary plan view illustrating an overview of a thirdvariation of the fifth form of manufacturing method, including aneleventh form nasal dilator in accordance with the present inventionproduced therefrom.

FIGS. 34 is a fragmentary plan view illustrating initial steps of thethird variation of method described with respect to FIG. 33 whereby toproduce the eleventh form of dilator device.

FIG. 35 is a fragmentary plan view illustrating subsequent steps of thethird variation of method described with respect to FIG. 33 whereby toproduce the eleventh form of dilator device.

FIG. 36 is a fragmentary plan view illustrating initial steps involvedin the third variation of method of FIG. 33 whereby to producecomplementary dilator devices.

FIG. 37 is a fragmentary plan view illustrating subsequent stepsinvolved in the third variation of method of FIG. 33 whereby to producea complementary dilator device.

FIG. 38 is a plan view illustrating two versions of a twelfth form ofnasal dilator in accordance with the present invention, produced ascomplementary devices from the third variation of method illustratedwith respect to FIGS. 36 and 37.

FIG. 39 is an exploded perspective view of the eleventh form of nasaldilator produced from the variation of method described with regard toFIGS. 33-35.

FIG. 40 is a plan view illustrating a comparison of resilient memberstructures.

FIG. 41 is a fragmentary plan view illustrating an initial step of asixth form of manufacturing method in accordance with the presentinvention, based on the methods of FIGS. 5a, 9a -9 b, and 23 a, and onthe comparison of resilient bands shown in FIG. 40.

FIGS. 42a and 42b are fragmentary plan views illustrating an overview ofa first set of subsequent steps to the sixth form of manufacturingmethod.

FIG. 43 is a fragmentary plan view illustrating an overview of a secondset of subsequent steps to the sixth form of manufacturing method.

FIG. 44 is a plan view of a thirteenth form of nasal dilator inaccordance with the present invention, produced from the methoddescribed with regard to FIGS. 41-42 b.

FIG. 45 is a plan view of a common form of nasal dilator, produced as asecond, complementary, device from the method described with regard toFIGS. 41-42 a.

FIG. 46 is a plan view of a fourteenth form of nasal dilator inaccordance with the present invention, produced from the methoddescribed with regard to FIGS. 41 and 43.

FIG. 47 is a fragmentary plan view illustrating an overview of initialsteps to a variation of the sixth form of manufacturing method wherebyto produce arcuately shaped dilator devices.

FIG. 48 is a fragmentary plan view illustrating subsequent steps to thevariation of the sixth form of manufacturing method whereby to producearcuately shaped dilator devices.

FIG. 49 is a plan view of an alternative form of the nasal dilator ofFIGS. 26 and 47, produced from the method described with regard to FIG.48.

FIGS. 50a-50c are fragmentary plan views illustrating a seventh form ofmanufacturing method in accordance with the present invention forproducing arcuately shaped devices.

FIG. 51 is a plan view of a fifteenth form of nasal dilator inaccordance with the present invention produced from the materiallaminate shown in FIG. 50 a.

FIG. 52 is a plan view of a sixteenth form of nasal dilator inaccordance with the present invention produced from the upper of twomaterial laminates shown in FIG. 50 b.

FIG. 53 is a plan view of a variation of the nasal dilator seen in FIG.28, produced from the lower of two material laminates shown in FIG. 50b.

FIG. 54 is a plan view of a four-band version of the nasal dilators seenin FIGS. 51 and 52, produced from the material laminate shown in FIG. 50c.

FIG. 55 is a fragmentary plan view illustrating an overview of an eighthform of manufacturing method in accordance with the present inventionwhereby to produce arcuate-like dilator devices along common linescorresponding to their upper long edges.

FIG. 56 is a plan view of a seventeenth form of nasal dilator inaccordance with the present invention produced from the method describedwith regard to FIG. 57.

FIG. 57 is a fragmentary plan view illustrating a variation of themanufacturing methods shown in FIGS. 5b-5c and 50 a, whereby to producearcuately shaped dilator devices on common longitudinal lines.

DETAILED DESCRIPTION OF THE INVENTION

An embodiment of a nasal dilator, 10, in accordance with the presentinvention is illustrated in FIG. 1. Seen in use, dilator 10 is affixedby its engagement element to a nose, 11, illustrated as a portion of ahuman face. Dilator 10 includes a directional element in the form of ahorizontal protrusion, 12, which separates slightly from the skinthereat as a result of the device's functional element applying springbiasing forces to the nasal wall tissues when dilator 10 is flexedacross the bridge of the nose.

FIG. 2 shows that dilator 10 comprises a laminate of vertically stackedlayers, indicated by a broken line, v, the layers including: a baselayer comprising at least one base member, 14, a resilient layercomprising at least one resilient member, 22, and a cover layercomprising at least one cover member, 18. A base, resilient or covermember may further include one or more components as part thereof.Portions of one layer may overlap another layer. A protective layer ofrelease paper, 15, removably covers exposed adhesive from any otherlayer preliminary to using the dilator. The shape and dimensions ofrelease paper 15 may correspond to the periphery of dilator 10 or mayexceed the periphery of one or more dilators 10. Release paper 15 may bebisected into two parts, which may overlap or abut, so as to facilitateremoval from the dilator prior to use. Dilator layers may be secured toeach other by any suitable means such as stitching or fastening, heat orpressure bonding, ultrasonic welding, or the like, but are preferablylaminated by an adhesive substance disposed on at least one flat surfaceside of at least one layer. At least a portion of one flat surface ofthe base or cover layer is preferably laminated to one of two flatsurfaces of the resilient layer. Dilator layers are preferably alignedalong a longitudinal centerline, a, shown by a broken line.

The peripheral dimensions of dilator 10 are defined by the cover layer,but may also be defined by the base layer, or a combination of layers orportions thereof. The base and cover layers may have the same dimensionor peripheral shape as each other, or the base and resilient layers maybe identical, or all three layers may have different peripheraldimensions. The base and cover layers of dilator 10 may be interchanged,or one or the other may be eliminated in whole or in part.

All or part of the base and cover layers, either separately or combined,together with a biocompatible adhesive thereon for affixing dilator 10to the skin, provide the primary engagement element of dilator 10.Adhesive may also be used on the functional element, should it contactthe skin directly, to thus aid engagement of the device to the skin. Theengagement element, by itself, does not provide nasal dilation, althoughdepending on the material used, could provide some tissue stabilization.The functional element, by itself and affixed to the skin by adhesive,will not generally remain engaged thereto. Accordingly, nasal dilatorsof the present invention combine separate functional and engagementelements in a single body device.

Where the base layer has a significantly lesser surface area than thecover layer, adhesive on the skin-engaging side of the base layer may beoptionally eliminated. With or without adhesive, the base layer may alsoserve as a compressible buffer between the device and the skin, as hasbeen historically common in medical devices which remain in contact withthe skin for any length of time. Dilators of the present invention aredesigned so that no portion of a layer extends substantially onto theskin surface areas of the cheek.

The preferred material for the base and cover layers is from a group ofwidely available medical grade flexible nonwoven synthetic fabrics thatare breathable and comfortable on the skin. Any suitable fabric orthermoplastic film, including various clear films, may be used. Apressure sensitive adhesive, biocompatible with external human tissue,is preferably disposed on at least one flat surface side of thematerial. A protective layer of release paper liner covers the adhesive.The preferred materials are typically available in rolls wound in themachine direction (MD) or warp, which is perpendicular to the crossdirection (XD) or fill, of the material. The manufacturing methods ofthe present invention have the base and cover layers fabricated parallelto the machine direction of the material, but they may be fabricatedparallel to either the warp or fill of the material.

The preferred material for the resilient layer is a widely availablebiaxially oriented polyester resin (PET), a thermoplastic film havingsuitable spring biasing properties across both its warp and fill. PET isused in a number of medical device applications and is particularlysuitable for nasal dilator devices. The film may have a pressuresensitive adhesive disposed on one or both surfaces with a protectivelayer of release paper liner covering the adhesive. PET may be laminatedto the preferred base layer material, from the adhesive side thereof tothe non-adhesive side of the base layer material, so that the resilientand base layers of dilator 10 may be fabricated simultaneously to thesame peripheral shape.

The functional element of dilator 10 is configured to provide springreturn biasing force within a suitable range as described hereinbefore.Spring biasing force is generated from the resilient layer of dilator10, the amount of which is determined by configuration of the resilientmember or members, and the length, width and thickness thereof. Theresilient layer preferably has an adhesive substance disposed on atleast a portion of at least one of two opposite flat surface sides forengaging or laminating it to other layers, members or components ofdilator 10, or for adhering to the nasal outer wall tissues. FIG. 2shows resilient member 22 having terminal end portions, 23, which alignwith a portion of the end edges of dilator 10, conforming substantiallyto protrusion 12 as shown in FIGS. 1, 3 and 4.

FIGS. 3 and 4 show that the layers of dilator 10 form a unitary, orsingle body, truss, 30, having a horizontal length, or longitudinalextent, c, indicated by a bracket. Truss 30 has contiguous regionsindicated approximately by broken lines and brackets, including a firstend region, 32, a second end region, 34, and an intermediate region, 36,which joins first end region 32 to second end region 34. The width ofintermediate region 36 is preferably narrower than the width of endregions 32 and 34. Portions of any layer may define a region of thetruss or a portion thereof. The layers, members or components of dilator10 may extend from one region to another. End regions 32 and 34 areadapted to engage outer wall tissues of the first and second nasalpassages respectively. Each end region has an end edge, 33.

Dilator 10 may further include a directional element throughconfiguration or modification to its layers or to the material webs fromwhich the layers are fabricated. A directional element may be formed bycuts, notches, openings, or the like, to create a discontinuity of shapeof material, a material separation, or a protrusion. A materialseparation may be formed in a dilator layer or a corresponding materialweb in the course of fabricating a layer, or formed in a materiallaminate, or formed as dilator 10 or its layers are die cut from amaterial laminate. End edge 33 includes a directional element in theform of a material separation, 13, formed as a back cut extending inwardfrom each end edge 33 and positioned between one long edge of terminalend portion 23 and the corresponding upper or lower tab extension, 35,adjacent thereto. Material separations 13 and terminal end portion 23together define protrusion 12 at end regions 32 and 34 of truss 30. Tabextensions 35 preferably extend horizontally beyond protrusion 12.

As a directional element defined by material separations 13, protrusion12 separates slightly from the skin when dilator 10 is engaged to nose11, as illustrated previously in FIG. 1. Material separations 13 allow achange in the angle of focused spring biasing forces, at least in part,and thus shifts or transforms at least some of these forces fromprimarily peel and tensile forces into primarily shear forces. Saidchange in angle further redistributes or imparts said transformed forcesto tissue engaging surface areas of the end regions, such as tabextensions 35, extending beyond the material separation. Spring biasingforces are thus imparted to the lateral width and longitudinal extent ofend regions 32 and 34, as opposed to a greater delaminating tendency,such as that from peel forces, being imparted to a lesser extent. Shearforces are more easily withstood by the tissue engaging adhesivesdisposed on the engagement element of dilator 10 than are peel forces.

A directional element may also be formed in the resilient layer by:varying the dimensions of the resilient layer or a member or componentthereof, such as by forming a gradiently tapered width; by theperipheral shape of the resilient member or divergent componentsextending therefrom; or by utilizing a plurality of resilient members,including resilient members of different thickness or width, with eachcontributing, to differing degrees, a portion of the total springbiasing force of dilator 10. Multiple resilient members of differentwidths and thickness affect, or direct, the functional element relativeto the dilator's overall peripheral dimensions, the dimensions of theresilient layer, and the total number of resilient member bands.Multiple resilient bands of varied width or thickness also allow greaterversatility and precision in achieving a desired spring biasing force,particularly where three or more resilient bands are used.

As seen in FIG. 4, the truss is symmetric on both sides of its lateralcenterline, b, and symmetric on both sides of its longitudinalcenterline a, both sides being the mirror image of the other. The upperand lower dilators 10 shown in FIG. 4 are laterally spaced apart, asindicated by a bracket, d, extending between their respectivecenterlines a. That amount of lateral spacing is typical in nasaldilator converting, as discussed hereinbefore, where material from whichfinished devices or device elements are fabricated is also used as amatrix by which to space finished devices apart.

A bracket and broken lines indicates an example of the dynamicrelationship between device design and manufacturing method in thepresent invention: devices are fabricated to be staggered lengthwise sothat portions of long edges corresponding approximately to the endregions thereof are fabricated on common die cut lines. Additionally,the device is configured so that two opposing end regions of twosuccessive device peripheries fit into the space between, andsubstantially on common lines with, the long edges of the deviceextending between opposite tab extensions 35. Embodiments of the presentinvention disclose means for fabricating medical devices on common linesor otherwise in close proximity, followed by means to space rows offinished devices apart to facilitate the packaging thereof. FIG. 4illustrates how material extending between what would otherwise belaterally spaced devices can be utilized in device construction so as togain manufacturing efficiency.

FIGS. 5a-5d illustrate a first manufacturing method in accordance withthe present invention, applicable to a variety of medical devices, butparticularly suited to a dilator device as seen in FIG. 4. FIG. 5a showsa plurality of a continuous slit, 25, formed in an elongated web ofresilient layer film, 24, spaced across the width thereof. Slits 25 forma plurality of an elongated resilient layer strand, 26. Strands 26 arelaterally contiguous, as shown by a bracket, d, their long edges formedon common longitudinal lines. Continuous slits 25 extend verticallythrough resilient layer film 24 and parallel to the machine directionthereof. Slits 25 are straight, and strands 26 are shown uniform inwidth.

Each strand 26 effectively consists of a successive plurality ofinterconnected resilient members. The width of strand 26 is configuredto form resilient members having suitable spring biasing properties whencut to finished length, but also configured so that a predeterminednumber of laterally contiguous strands 26 have a predeterminedcollective width. In the present instance, resilient layer film 24includes a base layer material laminated thereto, so strands 26 alsoconsist of a plurality of interconnected base layer members. The baselayer of finished dilators 10 will thus have the same dimension as theresilient layer. Accordingly, an adhesive substance is not required onthe exposed side of the base layer material opposite resilient layerfilm 24, since the cover layer of the finished dilator device mayadequately serve as the engagement element.

As seen in FIG. 5b , a plurality of an abbreviated slit, undercut 38, isformed at intervals in a separate elongated web of release paper liner,41. Each undercut 38 is positioned to correspond approximately to thelateral centerline of where a finished dilator will be die cut. Threeadjacent, laterally contiguous resilient layer strands 26 form a group,29, as indicated by broken lines and brackets. While maintainingposition relative to the other strands, one strand 26 from each group 29is separated from resilient layer film 24 and combined with paper liner41 and an elongated web of cover layer material, 44 to form an elongatedmaterial laminate, 40.

Predetermined strands 26 are registered in a lateral, spaced apart,relationship across the width of material laminate 40, the intervalsdetermined by the width of group 29. Cover layer material 44 islaminated by its adhesive side onto separated resilient layer strands 26and separate release paper liner 41. The remaining strands fromrepeating groups 29, illustrated by dashed lines, are in position to beseparated onto paper liners and the process repeated.

The skilled converter will see that if the base layer material laminatedto resilient layer film 24 includes an adhesive layer on the oppositeside thereof, the protective release paper liner which covers it must behandled in one of two ways: If slits 25 extend through the paper liner,then respective portions thereof are removed from each of the strands 26as they are layered onto separate paper liner 41. In this way strands 26not so separated may be rewound for later processing with theirrespective paper liners intact. Alternatively, slits 25 may extendthrough resilient layer film 24 to, but not through, the paper liner(i.e., a kiss cut technique), in which case strands 26 are peeledtherefrom and directly onto separate paper liner 41.

Dilator devices of the present invention are manufactured lengthwise,parallel to the machine direction of the materials. To continue thepresent method, FIG. 5c shows a plurality of a continuous slit, 45,extending vertically through laminate 40 and longitudinally along themachine direction thereof, diverging laterally in a repeating patternwithout intersecting the outside long edges of laminate 40 or anadjacent slit 45. Two adjacent slits 45 extend along opposite long edgesof each resilient layer strand 26, preferably spaced equidistanttherefrom. Slit 45 adjacent each long edge of laminate 40 together forman outside waste strand, 47.

Each slit 45 forms the respective long edges of longitudinally staggeredand laterally adjacent finished dilator devices. Cross slits, 48, bisectmaterial laminate 40 at prescribed intervals between adjacent slits 45to form dilator end edges. Cross slits 48 sever strands 26 to formresilient members 22, protrusions 12, terminal end portions 23 andmaterial separations 13. Continuous slits 45 and cross slits 48 may beformed simultaneously. Cross slits 48 should not cut into the resilientlayer strand at material separations 13. End edges 33 could be of asimpler configuration so as to increase the margin of error in thisregard. (Less preferable, a single cross slit 48 could be used insteadof two, thus forming opposite end edges 33 of two successive finisheddilators on a common die cut line.)

As seen more clearly in FIG. 5d , continuous slits 45 and cross slits 48separate material laminate 40 into a plurality of loose finished dilatorunits, waste pieces, 49, and waste strands 47 (all of which are shownslightly separated for visual clarity). Adjacent dilators 10 are formedlaterally contiguous where their long edges abut, as previouslyillustrated in FIG. 4. The lateral spacing of resilient layer strands26, determined by the individual and collective widths thereof, alsodefines parameters for the width of finished dilator devices and thelateral spacing of slits 45. Waste pieces 49 are preferably punchedthrough laminate 40 and collected, while waste strands 47 may bere-wound. The resultant plurality of finished individual nasal dilators10 are then captured in bulk.

FIGS. 6a-6c illustrate alternative steps to those illustrated in FIGS.5c and 5d . FIG. 6a shows resilient layer strands 26 separated fromgroups 29 and incorporated into material laminate 40 as before. In thisinstance, however, the resilient layer film from which resilient layerstrands 26 are slit does not include a base layer material laminatedthereto, but preferably does include an adhesive layer on one side.

Strands 26 are combined with elongated webs of base layer material, 42,and cover layer material 44, illustrated by dashed lines, to formmaterial laminate 40. Base layer material 42 has an adhesive substancedisposed on what will be the skin-engaging side, protected by a paperliner. Enclosed die cut lines, 52, represented by dashed lines in FIGS.6a and 6b , form finished dilator units as more particularly illustratedin FIG. 6c . Undercut 38, illustrated by dashed lines, may be formed inthe paper liner of base layer material 42 in advance, or concurrent withthe formation of die cut lines 52.

FIG. 6b illustrates that continuous slits 45 divide material laminate 40into a plurality of adjacent, laterally contiguous, laminate strands,46. For illustrative clarity, laminate strands 46 are shown slightlyseparated from each other in the drawing figure. Each slit 45 alsodefines long edges, 45′, of two laterally adjacent laminate strands 46.Slit 45 adjacent each outside long edge of laminate 40 defines one longedge of a laminate strand 46, and together with the long edge oflaminate 40 forms outside waste strand 47.

FIG. 6c shows every other laminate strand 46, while maintaining itsposition by the width of the strand 46 therebetween, represented bydashed lines, is separated from laminate 40 and layered an elongated orcontinuous packaging material web, 60 a, to form a fabrication matrix,50. The remaining laminate strands 46, having the same lateral spacingtherebetween, are positioned to be layered onto a packaging material webas well.

FIG. 6c further illustrates that enclosed die cut lines 52 form finisheddilators in cookie-cutter fashion within the perimeter of laminatestrand 46 at prescribed intervals along the length thereof. Die cutlines 52 extend vertically through laminate strand 46, to, but notthrough, packaging web 60 a. The skilled converter will note that,generally, either of two packaging material webs may form the foundationof fabrication matrix 50 to which finished devices are kiss cut, andthat cutting may extend vertically through material laminate 40 fromeither side, as dictated by preference or machine setup.

Die cut lines 52 sever resilient layer strands 26 into resilient members22, and form end edges 33, protrusions 12, terminal end portions 23 andmaterial separations 13 of dilator 10 as described previously. Materialfrom around and between die cut lines 52 extending to the opposite longedges 45′ of laminate strand 46 is removed as a continuous waste matrix,53, leaving a plurality of spaced apart finished dilators on packagingweb 60 a. Separating every other laminate strand 46 creates lateralspacing between finished devices so that the second of two packagingwebs, 60 b, may form an adequate perimeter seal with packaging web 60 aaround and between dilators 10, encapsulating them therebetween.Packaging webs may be of any suitable material, such as paper orthermoplastic film, and may be sealed by adhesive, heat bonding,compression, or the like. The sealed packaging webs may be cut, slit,perforated or scored between one or more individual dilators 10 as ameans to segment dilators individually or into groups.

The preceding method of fabricating dilator 10 incurs more wastematerial, in the form of matrix 53, than that shown in FIG. 5d .However, the advantage is that finished devices are packaged in the sameoperation as that from which they are fabricated, with minimal increasein converting cost. FIGS. 7 and 8 more particularly illustrate thefinished dilator device. The base layer of dilator 10 has the sameperiphery as the cover layer. Its bowtie-like shape places progressivelymore tissue-engaging surface area along the lateral and longitudinalextents of each end region of the truss, similar to the dilator of FIGS.2-4. Dilator 10 further features a rectangular resilient member 22having material separations 13 and protrusions 12 as describedhereinbefore.

FIGS. 9a-9e illustrate a second form of manufacturing method, inaccordance with the present invention, applicable to a variety ofmedical devices, but particularly suited to a dilator device as seen inFIG. 10. In FIG. 9a a plurality of continuous slits 45 in base layermaterial 42 form adjacent, laterally contiguous base layer strands, 43.Continuous slits 45 extend longitudinally along the machine direction ofbase layer material 42, and extend vertically to the paper liner, 42′,on one side thereof. Slits 45 diverge laterally in a repeating patternwithout intersecting the outside long edges or an adjacent slit 45. Slit45 adjacent each long edge of base layer material 42 together formoutside waste strand 47. Strands 43 effectively consists of a successiveplurality of interconnected base members. Strands 43 are configured toform base members to design criteria suitable to the finished device,and also configured to have a predetermined collective width whichfacilitates alignment to a plurality of resilient layer strands.

As further seen in FIG. 9a , three adjacent pairs of resilient layerstrands 26 form group 29. Strands 26 are slit from resilient layer filmsubstantially as described hereinbefore, with the exception that threewaste strands (not shown) are formed and discarded to create a narrowspace in between the long edges of each pair of the six strands in eachgroup 29. The resilient layer film preferably has an adhesive substancedisposed on one side, and thus strands 26 are laminated to one side ofbase layer strands 43. The width of strand 26 is configured so as tohave suitable spring biasing properties when cut to finished length, andalso configured so that group 29 has a collective width such that onepair of resilient layer strands 26 from each group 29 align to thelongitudinal centerlines of every other base layer strand 43.

Configuring elongated strands to different widths and from separatematerial webs to meet required device design criteria, then aligning thestrands to each other, may require adjustments to the alignment process.In this instance, FIG. 9a shows that only one pair of strands 26 at atime, from each group 29, align to respective centerlines of base layerstrands 43. Groups 29, collectively, as a unit, must then be shiftedlaterally so that the second of three pairs of strands 26 align to thelongitudinal centerlines of the remaining base layer strands 43, as moreclearly seen in FIG. 9b . The second of pairs of strands 26 are combinedthereon as just described. The third, leftover, three pairs of strands26 may be recoiled, or may follow the previous strands onto the baselayer material, or may be combined with a subsequent base layer materialweb. The skilled converter will see that this 3:2 ratio of strands(three pairs of strands 26 to two adjacent strands 43), respectively, isconstant regardless of the width of base layer material 42 or the totalnumber of elongated strands.

As further seen in FIG. 9b , every other base layer strand 43, includingthe pair of resilient layer strands 26 aligned thereon, is separatedfrom paper liner 42′, as indicated by broken lines, and layered onto aseparate release paper liner 41. Both first and second sets of pairedstrands 26 from groups 29 may be aligned to base layer strands 43 beforeseparating combined strands onto paper liner 41, as described, oralternatively, the first set of paired strands 26 may be combined withstrands 43 and removed onto paper liner 41 before proceeding to thesecond set. Regardless, all of the combined strands 26 and 43 maintainlateral spacing therebetween.

The preceding steps apply whether or not base layer material 42 includesan adhesive layer thereon, covered by paper liner 42′. In the event baselayer material 42 does not include adhesive, first and second sets ofresilient layer strands 26 may be laminated to base layer material 42before forming base layer strands 43 (it being understood that thecutting knife height be sufficient to accommodate the thickness ofstrands 26). Strands 26 will inhibit any inadvertent stretching of thebase layer strands 43 as combined strands 26 and 43 are removed ontoseparate release paper liner 41. In the event base layer material 42includes an adhesive layer, slits 45 may alternatively extend throughpaper liner 42′, in which case each base layer strand 43 would have thepaper liner portion removed as the combined strands 26 and 43 arelayered onto separate paper liner 41.

Concurrent with separating combined strands 26 and 43 onto separaterelease paper liner 41, FIG. 9c , shows two webs of elongated coverlayer material 44 laminated by their adhesive sides to exposed surfacesof resilient layer strands 26, base layer strands 43 and paper liners 41and 42′ to form two material laminates 40. At this point, paper liner42′ is effectively the same as separate release paper liner 41, and forsimplicity is referenced accordingly in the drawing. Combined resilientlayer strands 26 and base layer strands 43 are effectively divided ontoseparate paper liners, positioned in a spaced apart relationship. Thatspacing is determined by the configuration of base layer strands 43 andthe width of group 29. Each laminate 40 thus comprises release paperliner 41, base layer strands 43, resilient layer strands 26, and coverlayer material 44. Paper liner 41 is the foundation of laminate 40,providing the surface against which dilators 10 are kiss cut, asillustrated in FIGS. 9d and 9 e.

Base layer material 42 generally carries a lower cost per unit ofmeasure than the resilient layer film, but a greater cost than coverlayer material 44. While it is often expedient to form the base andcover layer members simultaneously to the same periphery, the presentmethod forms and separates base layer strands 43 to create a partialbase layer in the finished device, and thus extending the yield of baselayer material 42. The technique doubles the number of base layermembers per unit of material, with only a modest increase in convertingtime to separate base layer strands onto paper liners 41.

Returning now to FIG. 9d , enclosed die cut lines 52 extend verticallythrough material laminate 40 to, but not through, release paper liner 41at prescribed intervals to form rows of successive finished dilatorunits. Die cut lines 52 are preferably aligned laterally to thecenterlines of base layer strands 43 and aligned longitudinally to thewider portions thereof, so that said wider portions correspondsubstantially to the intermediate region of finished dilator units.

FIG. 9e shows continuous waste matrix 53 removed from around and betweendie cut lines 52, leaving a plurality of spaced apart finished dilators10 releasably secured to release paper liner 41. Waste matrix 53 isseparated as a single matrix by virtue that cover layer material 44extends across the width of paper liner 41. Waste matrix 53 includesgreater portions of cover layer material, extending around and betweenfinished dilators, and lesser portions of base layer and resilient layermaterial, extending between successive finished dilators. (As noted,cover layer material 44 generally carries a lower cost than base layerand resilient layer materials.) Paper liner 41 may be bisected, as shownin FIG. 9e , or otherwise slit, perforated or scored between one or moreindividual dilators 10 as a means to segment dilators individually orinto groups. The segments may be further encapsulated between packagingwebs, 60 b and 60 a, as shown in FIG. 10.

FIG. 10 more particularly illustrates a plurality of finished dilators10 releasably secured to a single release paper 15, the periphery ofwhich extends slightly beyond their collective surface area. Dilator 10features two parallel resilient members 22, wherein terminal endportions 23 correspond to a single protrusion 12. Base member 14 hasless surface area than the cover layer, but a greater surface area thanthe resilient layer, and is positioned where it contributes most todevice efficacy: interposed between at least the peripheral extent ofresilient layer and the skin surfaces engaged by dilator 10,substantially where the device contacts the bridge of the nose. Thisleaves less surface area at the device end regions and a single materiallayer at the device tab extensions, allowing greater moisture vaportransmission from the skin surfaces thereat which contributes to usercomfort.

A dilator device shown in FIG. 11 also features a base layer having aperiphery greater than the resilient layer and lesser than the coverlayer. Base member 14 is interposed between at least the peripheralextent of resilient layer and the skin surfaces engaged by dilator 10,and eliminated from the tab extensions. The dilator devices of bothFIGS. 10 and 11 feature substantially rectangular resilient members,having material separations 13 adjacent terminal end portions thereof,together with protrusions 12 as described hereinbefore.

FIG. 12 illustrates a variation to the second form of manufacturingmethod described with regard to FIGS. 9a -9 e, wherein elongated strandsare formed from both base layer and cover layer material webs. Thisvariation of method is applicable to a variety of medical devices ofwhich the dilator seen in FIG. 11 is an example. Continuous slits formlaterally contiguous resilient layer strands 26 and base layer strands43 from respective material webs as described hereinbefore. Elongatedstrips, 44′, are slit from cover layer material 44 and may be divided byevery other strip into two groups. The widths of strands 26 areconfigured to have suitable spring biasing properties when cut tofinished length, and the widths of strands 43 and strips 44′ meet designrequirements for the base and cover layers of finished dilator devices.Strands 26 and 43 and strips 44′ are also configured to individual andcollective widths which facilitate predetermined strands and stripsaligning to each other by their longitudinal centerlines.

There is a 3:2:1 ratio of three pairs of strands 26 to two adjacentstrands 43 to one strip 44′. The first one of each three laterallyconsecutive resilient layer strands 26 align to the longitudinalcenterline of each first of two laterally consecutive base layer strands43. Broken lines indicate where every other of combined strands 26 and43 are layered onto a separate release paper liner 41. Cover layermaterial strips 44′ are then layered onto the combined strands 26 and 43on each release paper liner 41, forming respective material laminates.The material laminates further include a first packaging web 60 a tocomplete respective fabrication matrices 50. The remaining second andthird out of three resilient layer strands 26 must be shifted laterally,as described hereinbefore, to re-align to the longitudinal centerlinesof the remaining second of two base layer strands 43 to repeat theprocess.

Strips 44′ are configured to encompass the width of a finished device,and dashed lines represent where die cut lines 52 extend verticallythrough fabrication matrices 50 to form rows of successive finisheddilators. Die cut lines may extend vertically through the materiallaminate from either side, kiss cutting against either packaging web 60a or 60 b, as dictated by the die cutting machinery. A plurality ofundercut 38 is preferably formed at intervals in paper liner 41, asdescribed hereinbefore.

Combining strands 26 and 43 and strips 44′ by forming, separating andaligning them onto separate paper liners 41 extends material yield andcreates lateral spacing between the rows finished devices so packagingmaterial webs 60 a and 60 b form an adequate perimeter seal. FIG. 13shows waste matrix 53 removed from fabrication matrix 50 (thefabrication matrices are identical, only one is shown), leaving aplurality of finished dilator units on packaging web 60 a to be sealedwith packaging web 60 b. Waste matrix 53 consists primarily of paper,and is separated as a single matrix by virtue that release paper liner41 extends across the width of fabrication matrix 50. The cost of paperliner 41 and packaging material webs 60 a and 60 b is considerably lowerper unit of measure than the base, resilient and cover layer materialswhich form finished dilator devices.

FIG. 14 illustrates an embodiment of a third form of dilator 10 inaccordance with the present invention, the fabrication of which isillustrated in FIGS. 15a-15f to follow. The device features a partialbase layer and a single rectangular resilient member. The device endedges are angled inward to correspond generally to the line where thenose meets the cheek of the user. By virtue of the manufacturing methodused, release paper 15 is not bisected into two parts. Instead, itswidth exceeds the periphery of dilator 10, providing a lip thereattogether with a lateral protrusion, 16, on each side of intermediateregion 36 that a user can grasp to separate dilator 10 from releasepaper 15 prior to use.

FIGS. 15a-15g illustrate a third form of manufacturing method, inaccordance with the present invention, applicable to a variety ofmedical devices, but particularly suited to the dilator device of FIG.14. FIG. 15a shows where continuous slits 45 form adjacent, laterallycontiguous base layer strands 43 in base layer material 42 as describedhereinbefore. Again, resilient layer strands 26 and base layer strands43 are configured to meet design criteria for the device produced, andalso configured to predetermined widths that allow select strands to beseparated from their respective elongated material webs in apredetermined spaced apart relationship. Every other resilient layerstrand 26 aligns to the longitudinal centerline of each consecutivestrand 43 and is combined thereon. For illustrative clarity, outsidewaste strands 47 are shown separated from paper liner 42′.

FIG. 15b illustrates every other of the combined resilient layer strands26 and base layer strands 43 separated from paper liner 42′ and layeredonto a separate release paper liner 41. Dashed lines between remainingstrands 43 represent from where every other of combined strands 26 and43 were removed. Concurrently, two webs of cover layer material 44 arelaminated by their adhesive sides to exposed surfaces of resilient layerstrands 26, base layer strands 43 and paper liners 41 and 42′ to formmaterial laminates 40. As discussed previously with regard to FIGS. 9band 12, the process effectively divides combined resilient layer strands26 and base layer strands 43 onto separate paper liners. And again,absent waste strands 47, paper liner 42′ is effectively the same asseparate release paper liner 41, and for clarity is referenced as suchin the drawing.

As seen in FIG. 15c , continuous slits 45 extend longitudinally alongthe machine direction of laminate 40 (for simplicity, only one materiallaminate 40 is shown), and vertically to, but not through, release paperliner 41 to form a plurality of laterally adjacent laminate strands 46.Slits 45 diverge laterally so as to form portions of the long edges ofstrands 46 on a common line. Portions of slits 45 also extend along thewider portions of base layer strands 43. Slit 45 adjacent each outsidelong edge of laminate 40 together form outside waste strands 47.Laminate strands 46 are releasably secured to paper liner 41 by at leastthe adhesive substance disposed on one side of at least cover layermaterial 44. Each strand 46 includes combined base layer strand 43 andresilient layer strand 26, and a portion of cover layer material 44.Strands 46 are laterally contiguous at those portions formed on a commonline.

FIG. 15d illustrates laminate strands 46 removed from material laminate40 leaving a waste matrix remnant thereof. For illustrative clarity,every other laminate strand 46 is represented by dashed lines, so thatthe configuration of laminate strand 46 is clearly seen. The wastematrix comprises a plurality of intermittent waste pieces 49 and outsidewaste strands 47 releasably secured to continuous release paper liner41.

The skilled converter will again see that slits 45 could alternativelyextend vertically through paper liner 41, in which case each laminatestrand 46 would include a corresponding paper liner portion that wouldbe removed prior to the next step, shown in FIG. 15e . The inherenttensile strength of the paper liner portion, together with the tensilestrength of resilient layer strand 26, would help prevent inadvertentlongitudinal stretching of the base and cover layer materials oflaminate strand 46 as they are separated from laminate 40. The wasteremnant of laminate 40 would then comprise outside waste strands 47 anda plurality of individual waste pieces 49, rather than the continuouswaste matrix shown.

The disposition of paper liner material notwithstanding, FIG. 15e showsevery other strand 46 layered onto additional separate release paperliners 41. A plurality of laminate strands 46 are divided anddistributed onto a plurality of paper liners 41, laterally spaced apartby a distance equal to the width of a strand 46 therebetween, asrepresented by dashed lines. This technique extends cover layer materialyield in the same manner as in extending the base layer and resilientlayer materials discussed previously. FIG. 15e further illustrates thateach combination of strands 46 and paper liner 41 are layered ontopackaging material web 60 a to form fabrication matrix 50.

FIG. 15f shows that die cut lines 52 kiss cut vertically throughfabrication matrix 50 to packaging web 60 a. The long edges of die cutlines 52 extend vertically through release paper liner 41, outboard andadjacent long edges 45′ of laminate strand 46. The lateral portions ofdie cut lines 52 bisect laminate strand 46 between long edges 45′. Thusedges 45′ of laminate strand 46 come to define the long edges ofsuccessive finished dilator units, while die cut lines 52 form end edges33 thereof and the long edges and outside corners of release papers 15which correspond to each finished dilator 10.

To complete the process, FIG. 15g shows continuous waste matrix 53separated from fabrication matrix 50, leaving a plurality of spacedapart finished dilators on packaging web 60 a. Waste matrix 53 includespaper liner 41 and sections of laminate strands 46 from around andbetween successive dilators 10. Again, waste matrix 53 consists almostentirely of low-cost paper, separated as a single matrix by virtue thatrelease paper liner 41 extends across the width of fabrication matrix 50(as more clearly seen in FIG. 15e ). Packaging webs 60 a and 60 bencapsulate finished dilators 10 therebetween, as describedhereinbefore.

FIGS. 16 and 17 a-17 d illustrate a fourth form of manufacturing methodand a fourth form of dilator 10 in accordance with the presentinvention. By way of an overview, FIG. 16 shows a plurality of resilientlayer strands 26 and 26 a formed on common longitudinal lines by slits25 from respective webs of resilient layer film 24 and 24′(substantially as shown in FIG. 5a ). Continuous slits 25 extendvertically through webs 24 and 24′, longitudinally along the machinedirection thereof, diverging laterally in a repeating pattern withoutintersecting the outside long edges of the resilient layer film web oran adjacent slit 25.

Strands 26 and 26 a are formed identical, but as the mirror image ofeach other: in web 24 strands 26 diverge to one side, in web 24′ strands26 a diverge to the opposite side. Slit 25 adjacent each long edge ofwebs 24 and 24′ together form an outside waste strand, 27. Slits 25 areparallel to each other and uniformly spaced, though strand widths mayotherwise vary according to the desired design attributes for themedical device to be fabricated. It should also be noted that by virtueof integrating strands 26 and 26 a from separate webs of resilient layerfilm 24 and 24′, one material web may be of a different thickness thanthe other, resulting in resilient layer strands of different thickness.

FIG. 16 also shows resilient layer strands 26 and 26 a combined withbase layer material 42, which has an adhesive substance disposed on oneside, covered by paper liner 42′. Strands 26 and 26 a are taken as pairsfrom respective webs 24 and 24′ and combined with base layer material 42so as to be in a predetermined, laterally spaced arrangement, thetechnique for doing so illustrated in FIG. 17a . Cover layer material44, shown in dashed lines, having substantially the same width asmaterial 42, is laminated by its adhesive side on top thereof tocomplete material laminate 40. Enclosed die cut lines 52, represented bydashed lines, show where finished dilator units will be die cut.

As discussed hereinbefore. resilient layer strands 26 and 26 a consistof a plurality of resilient members integrated into an elongated strand.In the present embodiment, strands 26 and 26 a have segments, 28 a, 28b, 28 c, 28 d, as indicated by broken lines and brackets, which repeatin a continuous pattern. Segments 28 a and 28 c correspond generally toend regions 32 and 34 of the truss, diverging from segments 28 b and 28d. Segment 28 b corresponds generally to intermediate region 36. Segment28 d interconnects successive resilient members and also sets thespacing, at least in part, between successive die cut lines 52.

As further seen in FIG. 16, enclosed die cut lines 52 form rows ofsuccessive dilators 10, each row registered laterally with pairedresilient layer strands 26 and 26 a. Die cut lines 52 are longitudinallypositioned along segments 28 a, 28 b and 28 c. Alternating pairs ofstrands 26 and 26 a are longitudinally staggered so that the long edgesof adjacent rows of dilator peripheries have substantially even spacingtherebetween. That spacing serves an intended purpose, as will becomeapparent in subsequent steps. The widest portions of die cut lines 52are formed along a common imaginary line, as indicated in the drawing bya broken line.

Now to begin the fabrication process, FIG. 17a illustrates fragmentaryportions of two groups of resilient layer film webs 24 and 24′ (absentoutside waste strands 27). The webs are aligned to other elongated webswhich will form material laminate 40. While the width of each resilientlayer film web is shown fragmentary, however, each web includes aplurality of adjacent, contiguous strands 26 or 26 a. The webs arepositioned in a staggered, overlapping relationship as indicated bybrackets. The webs are aligned such that individual strands 26 and 26 aare peeled from their respective webs and combined with base layermaterial 42 in the spaced apart arrangement illustrated in FIG. 16. Forillustrative clarity, webs of resilient layer film 24 are shown to theleft side of base layer material 42 and webs of resilient layer film 24′to the right side. In practice, the material webs would be positionedaccording to machine setup.

Broken lines indicate the first of each strand 26 and 26 a fromrespective webs of resilient layer film 24 and 24′ layered onto baselayer material 42. As each resilient layer strand 26 or 26 a is layeredonto base layer material 42, the two groups of webs 24 and 24′,collectively, are shifted laterally, as indicated by directional arrows,by a distance equal to the width of one resilient layer strand, to alignthe next strands to the positions formerly occupied by the strands justseparated. Once the desired resilient layer strands 26 and 26 a arecombined with base layer material 42, cover layer material 44, shown bydashed lines, is laminated by its adhesive side on top thereof tocomplete material laminate 40.

FIG. 17b shows where enclosed die cut lines 52 form of a plurality ofdilator units, defining the peripheries thereof at staggered, spacedapart intervals, as illustrated in FIG. 16. Die cut lines 52 extendvertically to, but not through, paper liner 42′ on the underside of baselayer material 42 of laminate 40. (Paper liner 42′ is shown slightlyenlarged in the drawing for clarity.) The waste material matrixextending around and between die cut lines 52 is removed, leaving aplurality of finished spaced apart dilators 10 releasably secured topaper liner 42′, as illustrated in FIG. 17 c.

At this point in the process, a plurality of finished dilator devicesare effectively captured in bulk on a contiguous paper liner. That maybe adequate for many medical device applications. However, to segmentfinished devices, FIG. 17c further illustrates continuous slits 45extending vertically through paper liner 42′ and longitudinally alongthe machine direction thereof. Slit 45 is formed in the spaces betweenthe long edges of laterally adjacent dilators 10. Slit 45 does notintersect a finished dilator, or the outside long edges of paper liner42′ or an adjacent slit 45. Slits 45 may extend between finisheddilators in any configuration, however, to seal finished devices betweenpackaging material webs, slits 45 divide paper liner 42′ into aplurality of an elongated finished strand, 39. Each strand 39 has rowsof successive finished dilators 10 releasably secured thereon. Each slit45 thus forms opposing long edges 45′ of two laterally adjacent finishedstrands 39. Slit 45 adjacent each outside long edge of paper liner 42′defines one long edge of strand 39, and together with each outside longedge of paper liner 42′ forms outside waste strands 47.

To package finished devices, FIG. 17d shows finished strands 39separated onto one or more packaging material webs 60 a. Strands 39maintain lateral spacing equal to the width of the strand 39 formerlytherebetween, as represented by dashed lines. Cross slits 48 extendlaterally between long edges 45′ and vertically to, but not through,packaging web 60 a, bisecting the release paper liner of strand 39 intosections with waste pieces 49 therebetween. Thus substantial portions oflong edges 45′ of strand 39 define the long edges of successive releasepapers 15 corresponding to successive dilators 10.

The peripheral edges of release paper 15 are outbound the periphery ofeach dilator 10, providing a lip thereat and a lateral protrusion 16 oneach side of intermediate region 36 that a user may grasp to separatedilator 10 therefrom. Waste pieces 49 (shown slightly separated forillustrative clarity) are removed from the surface of packaging web 60 ain between dilators 10 by any suitable means such as suction or targetedforced air. Packaging web 60 b then forms a seal with packaging web 60 aaround and between dilators 10 as described hereinbefore.

FIGS. 18 and 19 more particularly illustrate the finished device. FIG.18 shows adjacent resilient members 22 each having divergent components,22′, extending laterally from a rectangular mid section. Resilientmember components 22′ constitute a directional element, spreading springbiasing forces to a greater lateral surface area of the device endregions. A component 22′ may be shorter, longer, of different width,gradient, curved, etc., and may be configured differently in each endregion.

As more clearly seen in FIG. 19, dilator 10 is symmetric on both sidesof its lateral centerline, b, and symmetric on both sides of itslongitudinal centerline a. A material separation, valley 21, extendsinward from each end edge 33, interposed between resilient memberterminal end portions 23. Valley 21 may be of any shape, and likematerial separations 13, is configured to facilitate the separation ofprotrusion 12 and the shifting of spring biasing peel forces to shearforces as described hereinbefore. FIG. 19 further shows by dashed linesthat the peripheral shape of dilator 10 is conducive to common line diecutting, as discussed previously with regard to FIG. 4.

FIGS. 20-21 and FIG. 22 illustrate two dilator devices produced from amanufacturing method described with respect to FIGS. 23a-23f to follow.The dilator of FIGS. 20 and 21 is a variation of the device of FIGS.18-19, it's resilient members also having divergent components 22′. Thedilator of FIG. 22 is a fifth form of nasal dilator 10 in accordancewith the present invention, produced as a complementary device. Itfeatures a resilient member having long edges which taper from a widerrectangular portion to narrower terminal end portions, the extent ofwhich corresponds generally to the device end regions. The taperedportions constitute a directional element, reducing the spring biasingforce of the truss thereat. Base member 14 of both dilator devices isshown having the same peripheral shape as cover member 18.Alternatively, base member 14 could have the same peripheral shape asthe resilient member(s).

FIG. 23a illustrates an overview of a fifth form of manufacturingmethod, in accordance with the present invention, applicable to avariety of medical devices, but particularly suited to dilator deviceslike those seen in FIGS. 20-22. Slits 25 form different configurationsof resilient layer strands from a web of resilient layer film 24.Resilient layer film 24 may alternatively include a base layer materiallaminated thereto, as described hereinbefore. Continuous slits 25 extendvertically through web 24, longitudinally along the machine directionthereof, diverging laterally in a repeating pattern without intersectingthe outside long edges or an adjacent slit 25. Slit 25 adjacent eachlong edge of resilient layer film 24 together form outside waste strand27.

Slits 25 are configured to form two laterally spaced apart strands 26,which may be combined in the fabrication of the dilator devicerepresented by dashed lines at the top of FIG. 23a . To avoid wastematerial between opposing strands 26, a second strand, 26 b, is formedtherebetween. Strand 26 b, which might otherwise be waste material, isinstead processed into a complementary dilator device as shown by dashedlines at the bottom of FIG. 23 a.

Strands 26 and 26 b alternate consecutively across the width ofresilient layer film 24; the configuration of one strand defines, atleast in part, the configuration of the strand adjacent to it on eitherside. Similarly, the width of a strand defines the lateral spacingbetween the two strands adjacent on either side. The strands areconfigured so that resilient layer structures formed therefrom meetfunctional and directional element criteria for the dilator deviceproduced, and to predetermined widths that allow select strands to beseparated from resilient layer film 24 in a predetermined spaced apartrelationship, as discussed hereinbefore.

As noted previously, resilient layer strands 26 and 26 b consist of asuccessive plurality of resilient members integrated into an elongatedstrand. Broken lines and brackets in FIG. 23a indicate segments 28 a, 28b, 28 c, 28 d which repeat in a continuous pattern. Segments 28 a and 28c correspond to dilator device end regions, and segment 28 b correspondsgenerally to the intermediate region. Segment 28 d interconnectssuccessive resilient members and also sets the spacing betweensuccessive die cut lines 52. Segments 28 b and 28 d are the same length,thus each consecutive resilient layer strand 26 may be viewed as eitherthe mirror image of the previous, alternating in succession, or asidentical, but longitudinally staggered. Each consecutive strand 26 b isidentical and longitudinally staggered from the previous.

FIG. 23b illustrates lateral spacing between resilient layer strands 26and 26 b when the strands are separated. Dashed lines represent wherestrands 26 b formerly occupied the spaces between adjacent strands 26.Strands 26 are registered in a laterally spaced apart relationshipdetermined by the width of strands 26 b and vice versa. Separatingstrands into respective groups is not required for the manufacturingprocess; select strands 26 and 26 b may be peeled from resilient layerfilm 24 and combined into a material laminate without first beingseparated into respective groups.

FIG. 23c shows resilient layer strands 26 combined with elongated websof base layer material 42 and cover layer material 44 to form materiallaminate 40. Group 29 comprises two pairs of strands 26. One pair fromeach group is layered onto base layer material 42. Pairs not layered arerepresented by dashed lines, and may be combined into a second materiallaminate, or follow the first pairs of strands into the first materiallaminate. Cover layer material 44, preferably having substantially thesame width as base layer material 42, is laminated by its adhesive sideonto exposed surfaces of strands 26 and base layer material 42 tocomplete material laminate 40. Dashed lines represent where die cutlines 52 will form finished dilator units, as more particularlyillustrated in FIG. 23 f.

FIG. 23d shows the first and third strands 26 b from each group 29combined with laterally consecutive base layer strands 43. Base layerstrands are formed in an elongated web of base layer material having anadhesive layer thereon covered by paper liner 42′, as describedhereinbefore. Similar to combining elongated strands shown in FIG. 12,the collective width of four laterally spaced strands 26 b, which makeup group 29, corresponds to the collective width of two adjacent,contiguous, base layer strands 43. The second and fourth strands 26 bfrom each group 29, shown in dashed lines for illustrative clarity, maybe recoiled for later processing, or combined with base layer and coverlayer material in the same manner as the first and third strands 26 b.

Broken lines indicate every other base layer strand 43, includingresilient layer strand 26 b aligned thereon, separated from paper liner42′ and layered onto a separate release paper liner 41. (Dashed linesillustrate the spaces formerly occupied by the separated strands.)Combined strands 26 and 43 are thus laterally spaced apart on separaterelease paper liners 41 and 42′, respectively. Cover layer material 44,having substantially the same width as the paper liners, is laminated byits adhesive side to exposed surfaces of strands 43, strands 26 andpaper liners 41 and 42′, to complete each material laminate 40.

FIGS. 23e and 23f show each material laminate 40 combined with packagingmaterial web 60 a to form fabrication matrix 50. Die cut lines 52 extendthrough laminate 40 to packaging web 60 a, forming rows of finisheddevices. Waste matrix 53 is removed, leaving a plurality of spaced apartfinished devices such that packaging webs may form a perimeter sealbetween finished devices.

In FIG. 23e , waste matrix 53 includes portions of cover layer material44 extending around die cut lines 52, and portion of base layer materialstrands 43 and resilient layer strands 26 b extending between successivedie cut lines 52. Similarly, waste matrix 53 shown in FIG. 23f includesportions of cover layer material 44 and base layer material 42 extendingaround die cut lines 52, and portions of strands 26 extending betweensuccessive die cut lines 52. The sealed, finished devices may be furthersegmented by cuts or scores extending through the packaging webs inbetween one or more encapsulated devices.

The preceding method forms elongated resilient layer strands 26 and 26 bin equal numbers. By combining each two resilient layer strands 26 intoa pair, there are twice as many of the complementary device producedfrom the method, shown in FIG. 22, as the primary device, shown in FIGS.20 and 21. Assuming that equal numbers of both devices are desired,FIGS. 24a and 24b illustrate an alternative method of forming resilientlayer strands so that one pair of strands 26 are produced for eachsingle strand 26 b.

FIG. 24a shows slits 25 formed in resilient layer film 24 such that twostrands 26 are laterally followed by strand 26 b, followed by twoopposing strands 26, and again followed by strand 26 b. The upper set ofbrackets show segments 28 a-28 d of strand 26; the lower set of bracketsshow segments 28 a-28 d of strand 26 b. FIG. 24b shows resilient layerstrands 26 and 26 b separated into two groups to illustrate twice thenumber of individual strands 26 (sixteen) separated from (eight)individual strands 26 b, thus making equal pairs of strands 26 toindividual strands 26 b. For visual clarity, dashed lines are used toillustrate some strands.

FIGS. 25a and 25b illustrate the first of several variations, frommyriad possible, to the fifth form of manufacturing method discussedwith regard to FIGS. 23a and 23b . Like the resilient layer strandsshown in FIGS. 24a and 24b , strands 26 and 26 b of the presentembodiment are formed in equal numbers, alternating across the width ofresilient layer film 24. So as not to repeat previous disclosure, FIG.25a is limited to illustrating resilient layer strand configuration andthe matching of resilient strands to dilator devices. It is understoodthat the strands maintain their lateral spacing as illustrated whencombined into a material laminate, as described hereinbefore, and that amaterial laminate is formed as previously disclosed.

Broken lines and brackets indicate segments 28 a-28 c of resilient layerstrand 26 aligning with the horizontal regions of a first dilatordevice, shown by dashed lines at the top of FIG. 25a . Strand 26 isconfigured wide enough so that a single resilient member in the finisheddevice has suitable spring biasing properties. Broken lines and bracketsindicate segments 28 a-28 c of resilient layer strand 26 b aligning withthe horizontal regions of a complementary dilator device, shown bydashed lines at the bottom of FIG. 25a . FIG. 25b shows equal numbers ofstrands 26 and 26 b separated into two groups. Dashed lines representwhere strands 26 b formerly occupied the spaces in between strands 26.

FIG. 26 more particularly illustrates the finished dilator devices. Thefirst device, shown at the top of the figure has divergent resilientmember components 22′ corresponding substantially to respective endregions of the truss. The truss end regions also diverge laterally inthe same manner. The complementary device is a variation on the dilatorof FIG. 22, featuring a resilient member having long edges which tapergradiently from a wider rectangular portion to narrower terminal endportions 23. The longitudinal extent of the tapered portions correspondto the device end regions, and terminal end portions correspond toprotrusions 12, with material separations 13 adjacent thereto.

FIGS. 27-31 b illustrate a second variation to the preceding fifth formof manufacturing method. This variation forms three differentconfigurations of resilient layer strands from a web of resilient layerfilm to produce complementary dilator devices. FIG. 27 shows an overviewwherein continuous slits 25 form resilient layer strands 26, 26 a and 26b in resilient layer film 24 as described hereinbefore. The strands areformed in an alternating pattern which repeats laterally between thelongitudinal centerlines of consecutive strands 26, as indicated bybrackets and broken lines to the left of the drawing figure. Strand 26is substantially straight and slightly wider than strand 26 a. Strand 26has portions which diverge laterally, and strand 26 b is formed inbetween strands 26 and 26 a.

As seen at the top of FIG. 27, horizontal brackets with broken linesindicate segments 28 a-28 c of resilient layer strands 26, 26 a and 26 bcorresponding to the intermediate and end regions of truss 30. Strands26 and 26 a may be combined in the fabrication of at least two distinctdevices, one larger and one smaller, as shown by dashed lines. Where twostrands 26 b are separated laterally therebetween by strand 26, strands26 b may be combined in the fabrication of another device, optionallyincluding strand 26 therebetween, illustrated by dashed lines per thelower set of brackets at the bottom of FIG. 27. Segment 28 d of allstrands determines, at least in part, the spacing between die cut lineswhich form finished devices.

So as not to repeat previous disclosure, FIG. 27 is limited toillustrating resilient layer strand configuration and the matching ofresilient strands to dilator devices. It is understood that the strandsmaintain their lateral spacing as illustrated when combined into amaterial laminate, as described hereinbefore, and that the materiallaminates are formed by way of techniques described hereinbefore.

FIGS. 28 and 29 illustrate the dynamic relationship between strandwidths, strand spacing, and the resilient layer structures of finisheddilator devices produced by the present method. Broken lines in FIG. 28indicate the width of the resilient layer strand (26), which forms theupper resilient member 22 of dilator 10 on the right, corresponding tothe spacing between upper and lower resilient members 22 of dilator 10on the left. The width of the former determines the spacing of thelatter, and vice versa. Similarly, broken lines in FIG. 29 indicate theconfiguration of the resilient layer strands (26 b), which form adjacentresilient members 22 of dilator 10 on the right. That configurationaffects the spacing and divergent portions of uppermost and lowermostresilient members 22 of dilator 10 on the left. The configuration of theformer determines, in part, the configuration of the latter, and viceversa. A third resilient member, in between the uppermost and lowermostresilient members in the dilator on the left, may be optional in bothdilator devices, right and left.

FIGS. 28-29 also illustrate features of diverse dilator devices whichmay be produced from the present method. Dilator 10 to the right in FIG.28 is horizontally symmetric but laterally asymmetric. Each horizontalhalf of the truss on each side of lateral centerline b is a mirror imageof the other. The upper half of the truss is formed parallel tolongitudinal centerline a. The lower half diverges from longitudinalcenterline a at each end region of the truss. Upper resilient member 22aligns with the nasal valve, while lower resilient member 22 hasresilient member components 22′ to better engage outer wall tissues ofthe nostril or nasal vestibule. Lower tab extension 35 correspond tocomponents 22′. Each of two resilient members 22 may have a differentwidth, the upper member being, in this case, slightly wider than thelower. Valley 21 is formed as a narrow elongated opening between upperand lower resilient members.

The dilator to the left in FIG. 28 has identical adjacent resilientmembers each having tapered portions extending generally along endregions 32 and 34 to terminal end portions 23 and protrusions 12. Werethere an optional third resilient layer strand (26) remainingtherebetween, the resilient layer would have three laterally contiguousresilient members absent any separation between their respective longedges. In either case, the resilient members' collective width appliesspring biasing forces to a slightly greater vertical surface of the nosegiven the device's shape and size. Dilator 10 to the left in FIG. 29 isproportionately larger than its counterparts, and thus more suited forlarger noses. Its spring biasing forces are spread widely at end regions32 and 34 by virtue of divergent components 22′. Material separation 13is adjacent each tab extension 35, and valley 21 is positioned betweenthe middle protrusion 12 and upper and lower protrusions 12 to eitherside thereof.

Referring momentarily back to FIG. 27, opposing strands 26 b are themirror image of each other and longitudinally staggered where separatedlaterally therebetween by strand 26 a. That configuration is alsoillustrated at the top of FIG. 30. Strands 26 b may be combined to formanother useful resilient layer structure by shifting every other strand26 b longitudinally so as to align segments 28 b opposite each other, asindicated by broken lines, brackets, and a directional arrow. To alignstrands 26 b in this manner, separate resilient layer film webs 24 arearranged as shown at the bottom of FIG. 30. The webs must overlap oneanother, and may be staggered longitudinally, as indicated bydirectional arrows. A bracket with broken lines extending across thewidth of webs 24 indicates the desired alignment. For illustrativeclarity, some of the strands in the resilient layer film webs arerepresented by dashed lines.

The overlapping arrangement of resilient layer film webs 24 allowsopposing strands 26 b to be peeled away in matching pairs, as seen inFIG. 31a . (The technique is the same, in principle, as that discussedpreviously with respect to FIG. 17a .) FIG. 31b shows how every otherpair is combined into respective material laminates 40 using meansdescribed hereinbefore. Dashed lines illustrate where die cut lines 52form rows of finished dilators suitably spaced apart for sealing betweenpackaging webs.

FIG. 32 more particularly illustrates the finished dilator device ashaving adjacent resilient members 22 positioned closely along theirrespective shorter long edges. The tapered portion extends from inward,near the longitudinal centerline of truss 30, to outward, forming adirectional element which reduces the spring biasing force of the truss.The gradient edges also create a space in which to form valley 21.Protrusions 12 are thus positioned immediately adjacent materialseparations 13 and tab extensions 35. This end edge structure isconducive to the desirable design practice of shifting peel forces tosheer forces, as described hereinbefore.

FIG. 32 further illustrates that the truss is symmetric on both sides ofits lateral centerline, b, and symmetric on both sides of itslongitudinal centerline a. Both sides are the mirror image of the other.Laterally adjacent dilators may be staggered lengthwise so thatsubstantially all of their long edges are fabricated on a common die cutline, as illustrated by dashed lines and described previously withregard to FIG. 4. To facilitate common die cut line fabrication, theinside lateral edges of upper and lower tab extensions 35 are formed tothe same angle and corner radius. Additionally, the truss regions areconfigured so that the long edges of two opposing end regions of twosuccessive dilator peripheries fit into the space between, and on acommon line with, the inside lateral edges of tab extensions and thelong edge of the truss between the tab extensions of the dilatorperipheries adjoining on either side.

The device of FIG. 32 may be mass produced in a spaced apartrelationship, as illustrated in FIGS. 30-31 b. FIG. 32 illustrates thatthe device is also configured to be fabricated contiguously on commondie cut lines. The skilled person in the art may observe that theconfiguration of resilient layer strands 26 b in FIGS. 31a and 31bprecludes common line die cutting as shown in FIG. 32. However, adifferent resilient layer strand configuration, such as that discussedpreviously with regard to FIG. 5b, 6b , 12, or 17 a, may be adapted forthe purpose.

FIG. 33 illustrates a third variation of the fifth form of manufacturingmethod of the present invention. Continuous slits 25 form resilientlayer strands 26, 26 a, 26 b, as described hereinbefore, plus an insidewaste strand, 27′. The strands are formed in a repeating pattern acrossthe width in resilient layer film 24. Waste strand 27′ is formed inbetween two parallel strands 26 a at each point where the pattern isrepeated, as indicated by broken lines and brackets to the left of thedrawing figure. Strand 26 is straight, while strands 26 a divergelaterally. Each opposing pair of strands 26 b are laterally separated bya strand 26 therebetween.

Upper and lower sets of horizontal brackets with broken lines indicatesegments 28 a-28 c of the resilient layer strands aligning with dilatordevices. As seen in the upper set of brackets, dashed lines illustratestrand 26 and opposing strands 26 a aligning with dilator regions so asto form a triple resilient band resilient layer structure. The finisheddevice is depicted to the right thereof, showing divergent upper andlower resilient members and a straight middle resilient member. Materialseparations 13 are adjacent each upper and lower protrusion 12, andvalley 21 is positioned between the middle protrusion 12 and the upperand lower protrusion 12 on either side.

In the lower set of brackets dashed lines illustrate two opposingstrands 26 b, which would otherwise be waste material, combined to formresilient layer structures of two additional complementary devices.Strand 26 may be included between opposing strands 26 b in one of thetwo complementary devices shown, and as more particularly illustrated inFIG. 38.

FIGS. 34-35 and FIGS. 36-37, respectively, illustrate resilient layerstrands combined into respective material laminates. The lateral spacingbetween strands is determined by the width and configuration of strandsseparated from the spaces therebetween: FIG. 34 shows group 29comprising one resilient layer strand 26 with opposing strands 26 aadjacent either side. Strands 26 and 26 a are laterally separated by thewidth of strands 26 b formerly therebetween, and adjacent groups 29 areseparated by a the width of waste strand 27′ formerly therebetween.Waste strand 27′ is removed and discarded as necessary waste, andstrands 26 b are combined into another material laminate (as illustratedin FIGS. 36 and 37). This leaves groups 29 laterally positioned forcombining with base layer strands and a cover layer material web intomaterial laminate 40.

FIG. 34 shows each group 29 separated from resilient layer film 24 andlayered onto base layer strands 43, the latter having been formed inbase layer material 42 by continuous slits 45 as described hereinbefore.Strands 43 are configured to conform to device requirements and to alignwith groups 29. Every other strand 43, each with a group 29 thereon, areseparated onto one or more separate release paper liners 41 as shown inFIG. 35 (in the same manner as described previously with respect toFIGS. 9a-9c and 15a-15b ). Cover layer material 44, shown by dashedlines, is laminated by its adhesive side onto the resilient layerstrands, base layer strands 43 and separate release paper liner 41 tocomplete material laminate 40. Dashed lines illustrate where encloseddie cut lines 52 form rows of successive finished dilators 10 asdescribed hereinbefore.

FIG. 36 illustrates two pairs of opposing strands 26 b separated by thecollective widths of inside waste strand 27′ and strands 26 a (theformer represented by dashed lines, and the latter not represented forillustrative clarity). However, strand 26 may be included between someof the opposing pairs of strands 26 b as more clearly seen in FIG. 37.FIG. 37 shows every other of paired strands 26 b combined into materiallaminate 40. Pairs of strands not so combined are represented by dashedlines, and these may be combined into a separate material laminate.Enclosed die cut lines 52 form peripheries corresponding to finisheddilator units in a spaced apart relationship suitable for sealingbetween packaging webs. Two similar, complementary, dilator devices arethus formed in material laminate 40 by die cut lines 52. One of the twodevices includes a third resilient member provided by strand 26.

FIG. 38 more particularly illustrates the two complementary dilatordevices having similar narrow peripheries. The devices are comparativelysmaller and lighter than their larger counterpart produced by thisprocess, and thus more suited for smaller noses. One device has a tripleband resilient layer structure, and one device is formed as a doubleresilient band structure. Adjacent resilient members taper in the samemanner as shown previously. Resilient member terminal end portions 23 ofthe double resilient member band device correspond to respectiveprotrusions 12, with valley 21 therebetween, at each end edge of thetruss. The terminal end portions of the device having three laterallycontiguous resilient members correspond to a single protrusion 12 ateach end edge of the truss.

FIG. 39 more particularly illustrates dilator 10, as previously shown inFIG. 33, die cut from material laminate 40 shown in FIG. 35. Base member14 is interposed between at least the peripheral extent of resilientlayer and the skin surfaces engaged by dilator 10, its peripherycorresponding substantially to the resilient layer, yet distinct fromboth the resilient layer and the cover layer. The resilient layerfeatures three resilient members; the upper and lower resilient bandsfeature divergent components 22′ extending laterally from theintermediate region through end regions 32 and 34. The resilient layerfurther has a substantially rectangular center resilient member bandinterposed between the upper and lower resilient bands.

FIG. 40 illustrates several examples of rectangular single resilientband and multiple resilient band structures. For simplicity, multiplebands are shown substantially the same width and arranged closelyparallel each other. At the top of the figure, a single resilient bandand the pair of resilient bands below it represent average or typicalconfiguration found in nasal dilator art. Below that, a three bandstructure may be used to increase, by some degree or percentage, theamount of spring biasing force over that which is generally found in asingle band or double band structure. The same or similar spring biasingof from one to three bands may also be spread across four narrowerbands. And the increased spring biasing generated by one to four bandsmay be generated by a five or six still narrower bands. Additionally,one or more individual bands may be of a different width or thickness.Elongated resilient layer strands combined from separate resilient layerfilm webs, as illustrated herein, facilitates formation of resilientlayer structures having multiple bands of both different thickness andwidth.

FIGS. 41-43 illustrate a sixth form of manufacturing method, inaccordance with the present invention, applicable to a variety ofmedical devices, but particularly suited to dilator devices havingmultiple parallel resilient bands. So as not to repeat previousdisclosure, FIGS. 50a-50c illustrate resilient layer strandconfiguration, the combining thereof into material laminates, and thepositioning of die cut lines in the laminates. Resilient layer strandsare produced from webs of resilient layer film and distributed to thematerial laminates as required. It is understood that the strandsmaintain their lateral spacing as illustrated when combined into amaterial laminate, as described hereinbefore, and the material laminatesare understood to be completed by way of techniques described herein.

As seen in FIG. 41, alternating wider and narrower resilient layerstrands 26 and 26′, respectively, are slit from a web of resilient layerfilm (or alternatively, from two or more webs of different thickness) asdescribed hereinbefore. Slits 25 are preferably straight and respectivestrands 26 and 26′ preferably uniform in width.

FIGS. 42a, 42b and 43 show resilient layer strands 26 and 26′ separatedfrom resilient layer film 24 into respective material laminates. Thestrands in each material laminate are identical; each strand laterallyspaced apart by the width of the strand formerly therebetween. Asdiscussed previously, rather than resilient layer strands 26′ beingwaste material by which to laterally space strands 26 apart, slits 25configure both strands 26 and 26′ to be used in complementary devices.

FIGS. 42a and 42b illustrate that resilient layer strands 26 may beincorporated into material laminate 40 in two different ways. To theleft in FIG. 42a , groups 29 comprise five strands 26 each. The firstthree adjacent strands are incorporated into a first material laminate40 and the following two adjacent strands are placed into a secondmaterial laminate 40 (shown next to the first laminate 40). Enclosed diecut lines 52 form rows of dilator devices: Every other row of die cutlines 52 in the first laminate 40 is flipped laterally and islongitudinally staggered so that finished devices are positionedlaterally closer thereby using less engagement element material. In thesecond laminate 40, die cut lines 52 form a smaller complementary devicehaving two parallel resilient bands.

Alternatively, FIG. 42b shows group 29 comprising three resilient layerstrands 26. Each one in three adjacent groups 29 is combined intomaterial laminate 40 so that rows of successive die cut lines 52 havesuitable lateral spacing for packaging material webs to form a perimeterseal. Additionally, strips of cover layer material 44, having a widthslightly greater than that of the peripheries formed by die cut lines52, may be aligned with the longitudinal centerline of group 29 or diecut lines 52 (similar to that discussed previously with regard to FIG.12).

FIG. 43 shows a first plurality of resilient layer strands 26′ evenlyspaced apart as seen in FIG. 41. The spacing is equal to the width ofstrands 26 formerly therebetween, as represented by dashed lines. Asecond plurality of strands 26′ are intermingled with the firstplurality, positioned in the spaces therebetween and corresponding tothe same longitudinal centerlines as did strands 26. Two pluralities ofstrands 26′ are thus intermixed and laterally spaced as evenly aspracticable. Group 29 comprises six adjacent strands 26′. Every otheradjacent group 29 is combined into material laminate 40.

FIG. 43 further illustrates by dashed lines where enclosed die cut lines52 (only fragmentary portions thereof are shown) form longitudinallystaggered dilator peripheries, similar to that shown in FIG. 42a .Additionally, continuous slits 45 are placed in material laminate 40 inthe spaces between the long edges of adjacent rows of die cut lines 52to form elongated finished strands from which finished dilators are diecut (as described previously with regard to FIGS. 17b-17d ). The skilledperson in the art will recognize that groups 29 in FIG. 43 may beconfigured with different numbers of resilient strands so as to match avariety of dilator device sizes and widths.

FIGS. 42 and 43 each illustrate resilient layer strands having identicalwidth. The strands may be of different widths, and if slit from separateresilient layer film, of different thickness. Forming resilient layerstrands of different thickness allows both width and thickness to bedesign variables together with the number of resilient members whichform the dilator resilient layer.

FIGS. 44-46 more particularly illustrate finished dilator devicesproduced from the method of FIGS. 41-43. FIG. 44 shows dilator 10produced from the material laminate shown in FIG. 42a , oralternatively, from the material laminate shown in FIG. 42b . The devicehas three parallel resilient members 22 of progressively less length. Ifthe resilient members are the same width and thickness, a shorter bandwill have more spring biasing force than a longer band. The elements ofend edges 33 (protrusions 12, valleys 21, separations 13 and tabextensions 35) correspond generally to an inward angle, as indicated bybroken lines, established by the resilient bands' lengths. That anglealso corresponds generally to the line where the nose meets the cheek.

FIG. 45 shows dilator 10 fabricated from the material laminate shown inFIG. 42a . Dilator 10 is a conventional double band design, formed as acomplementary device to dilator 10 of FIG. 44. It is smaller in sizethan its counterpart, and thus suitable for smaller noses. The dilatorof FIG. 46, produced from the material laminate shown in FIG. 43, hassix narrow parallel resilient members 22. Three protrusions 12 at eachend edge 33, separated therebetween by two valleys 21, correspond toterminal end portions 23 of two adjacent resilient members 22. Materialseparations 13 are adjacent the upper corners of the uppermost resilientmember band and the lower corners of the lowermost resilient memberband, respectively.

FIGS. 47-48 illustrate an overview of an alternative to the sixth formof manufacturing method whereby to produce dilator devices having anarcuate-like shape (an example thereof illustrated in FIG. 26). Theintermediate region of an arcuate dilator device rests slightly higheron the bridge of the nose, its end regions positioned correspondinglylower than that of horizontally straight dilator devices, so as toengage outer wall tissues adjacent both the nasal valve and the nasalvestibule.

So as not to repeat previous disclosure, FIGS. 47-48 illustrateresilient layer strand configuration, the combining thereof intomaterial laminates, and the positioning of die cut lines in thelaminates. Resilient layer strands are produced from webs of resilientlayer film and distributed to the material laminates as required. It isunderstood that the strands maintain their lateral spacing asillustrated when combined into a material laminate, as describedhereinbefore, and the material laminates are understood to be completedby way of techniques described herein.

FIG. 47 shows two sets of alternating wider and narrower resilient layerstrands 26 a and 26 a′ slit from an elongated web of resilient layerfilm (or alternatively, from two or more webs of different thickness),similar to that illustrated with respect to FIG. 41. The strands divergelaterally in a continuous repeating pattern. Strands 26 a and 26 a′ maybe combined into separate material laminates without first being dividedinto respective groups of identical strands. Every other pair ofadjacent resilient layer strands 26 a are combined into materiallaminate 40. Dashed lines illustrate die cut lines 52 forming adjacentrows of successive finished dilator units, similar in appearance to thedilator of FIG. 26, where the end regions diverge as do the resilientmembers, giving the finished dilator the appearance of an arcuate shape.

FIG. 48 shows a first plurality of resilient layer strands 26 a′,separated from strands 26 a as seen in FIG. 47. Each strand 26 a′ islaterally spaced apart by a distance equal to the width of strand 26 aformerly therebetween, as represented by dashed lines. A secondplurality of strands 26′ are intermingled with the first plurality,positioned in the spaces between each strand 26′ and corresponding tothe same longitudinal centerlines, indicated by a broken line, asstrands 26 a. Both pluralities of strands 26′ are thus laterally spacedas evenly as practicable.

Every other adjacent group 29, comprising four resilient layer strands26 a′ each, is combined into material laminate 40. Die cut lines 52 formfinished dilator devices, similar to that shown in FIG. 47, where theend regions of the truss correspond to the divergent segments of strands26 a′. As noted previously, strands 26 and 26 a′ may be formed from webshaving different thickness. For example, resilient layer strands of theabove referenced second plurality, having a second thickness, may beintermingled with the first plurality of strands having a firstthickness. The four band resilient layer structure of the finisheddevice, more particularly illustrated in FIG. 49, would thus have everyother resilient member being one thickness or the other.

FIGS. 50a-50c illustrate a seventh form of manufacturing method, inaccordance with the present invention, applicable to a variety ofmedical devices, but particularly suited to arcuate dilator devices. Soas not to repeat previous disclosure, FIGS. 50a-50c illustrate resilientlayer strand configuration, the combining thereof into materiallaminates, and the positioning of die cut lines in the laminates.Resilient layer strands are produced from webs of resilient layer filmand distributed to the material laminates as required. It is understoodthat the strands maintain their lateral spacing as illustrated whencombined into a material laminate, as described hereinbefore, and thematerial laminates are understood to be completed by way of techniquesdescribed herein.

FIG. 50a shows alternating wider and narrower resilient layer strands 26a and 26 a′, similar to that illustrated with respect to FIGS. 41 and47, slit from a web of resilient layer film (or alternatively, from twoor more webs of different thickness) as described hereinbefore. Strands26 a and 26 a′ diverge laterally in a repeating pattern of successivecurved segments. Broken lines indicate that strands 26 a and 26 a′ areseparated into several material laminates.

FIG. 50a further illustrates the first two of each three consecutiveresilient layer strands 26 a combined as pairs with material laminate40, shown in dashed lines. Dashed lines also illustrate where die cutlines 52 form successive, laterally contiguous, rows of arcuate deviceperipheries on common longitudinal lines. The overall curvature of eachperiphery substantially follows the curvature of the resilient layerstrands. To further facilitate common die cut line formation, everyother row of peripheries is flipped laterally so that the lower longedges of one periphery are formed on a common die cut line with thelower long edges of the periphery adjacent thereto, and the upper longedges of one periphery are formed on a common die cut line with theupper long edges of the periphery adjacent thereto. The pattern repeatslaterally across the width of laminate 40.

FIG. 51 more particularly illustrates dilator 10 produced from materiallaminate 40 shown in FIG. 50a . The device is symmetric on each side oflateral centerline b, but asymmetric on each side of longitudinalcenterline a. To accommodate the continuous repeating curvature used inthe fabrication process, and to form substantial portions of the trusslong edges on common lines, upper tab extensions 35 have a slightlydissimilar peripheral shape than lower tab extensions 35. Additionally,as indicated by broken lines and brackets, the upper long edge ofintermediate region 36 is shorter than the lower long edge thereof.Also, the upper half of respective end regions 32 and 34 have a greaterlongitudinal extent than the lower half. To follow the repeatingcurvature of the resilient layer strands, the long edges of the endregions are formed to have the same radius, but reverse curvature, ofthe intermediate region: the long edges of upper tab extensions 35 andthe lower long edge of intermediate region 36 curve laterally inward,and the long edges of lower tab extensions 35 and upper long edge of theintermediate region 36 curve laterally outward.

Returning now to FIG. 50b , broken lines indicate the third of eachthree consecutive resilient layer strands 26 a from FIG. 50a separatedas a first plurality from strands 26 a′. The strands are combined intothe upper of two material laminates 40 shown in FIG. 50b . The firstplurality of strands 26 a is followed by a second plurality thereof,intermingled with the first plurality so as to form pairs of strandslaterally spaced apart. Every other pair of strands is then combinedinto material laminate 40. Dashed lines illustrate where die cut lines52 form rows of finished dilators suitably spaced apart for sealingbetween packaging webs. The finished dilator device is generallyillustrated in FIG. 52.

Additionally, or alternatively, broken lines indicate that the third ofeach three consecutive resilient layer strands 26 a from FIG. 50a mayalso be combined into the lower of two material laminates 40 shown inFIG. 50b . The strands are combined with strands 26 slit from a separateresilient layer film web, which may optionally be of a differentthickness. Each one in four select strands 26, from contiguous groups29, are combined with strands 26 a to form pairs. Each pair comprises acurved strand 26 a and a straight strand 26. The pairs of strands arelaterally spaced apart, with every other pair combined into materiallaminate 40. Dashed lines illustrate where die cut lines 52 form rows offinished dilators suitably spaced apart for sealing between packagingwebs. The finished dilator device is illustrated in FIG. 53.

As seen in FIG. 50c , broken lines and brackets also indicate wherestrands 26 a′ from FIG. 50a are separated as a first plurality fromstrands 26 a, to be combined into material laminate 40. The firstplurality of strands 26 a′ is followed by a second plurality thereof,intermingled with the first plurality so as to form laterally spacedgroups of four strands 26 a′ each. Every other group of four strands isthen combined into material laminate 40. Dashed lines illustrate wheredie cut lines 52 form rows of finished dilators suitably spaced apartfor sealing between packaging webs. The finished dilator device isillustrated in FIG. 54.

FIG. 52 illustrates a representative example of the arcuate dilatordevice produced from material laminate 40 seen at the top of FIG. 50b .The long edges of the truss, particularly at the intermediate region,substantially follow the same curvature as two parallel resilientmembers. The long edges of upper and lower tab extensions 35 may curvein the same or similar manner. The lower resilient member is longer thanthe upper member, and lower tab extensions 35 extend slightly beyond theupper tab extensions 35. The truss's end edge elements thus angleinward, as indicated by broken lines, to correspond generally to theline where the nose meets the cheek.

FIG. 53 illustrates the semi-arcuate dilator device produced frommaterial laminate 40 seen at the bottom of FIG. 50b . The device isparticularly similar to the dilator shown to the right in FIG. 28, beinghorizontally symmetric and laterally asymmetric. Upper tab extensions 35and upper resilient member 22 are parallel to the longitudinalcenterline of the truss, intended to align with the tissues immediatelyadjacent the nasal valve. The divergent portions of the arcuateresilient member align with the nasal outer wall tissues adjacent thenostrils or nasal vestibule. Lower tab extensions 35 diverge in the samemanner, and may extend slightly beyond upper tab extensions 35. Thetruss's end edge elements thus angle inward, as indicated by brokenlines, to correspond generally to the line where the nose meets thecheek.

FIG. 54 illustrates the arcuate dilator device produced from materiallaminate 40 seen in FIG. 50c . The device is a four-band resilient layerversion of the dilator device shown in FIG. 52, and is also similar tothe dilator of FIG. 49. The arcuate shape of the truss substantiallyfollows the curvature of the four parallel resilient members. Thetruss's end edge elements are angled inward, as indicated by brokenlines, following the resilient members' progressively shorter length.Spring biasing is thus slightly greater toward the upper part of thedevice. Terminal end portions 23 correspond to respective protrusions12, with valleys 21 therebetween, at each end edge of the truss.

The manufacturing method of FIGS. 50a-50c is particularly suitable forcontinuous rotary die press converting. The skilled converter may notethat alternatively, an arcuate device and its constituent elements,members or components could be formed in a circular pattern within amaterial sheet of fixed size, such as that used in a flat bed presssystem. Flat bed systems are more suited to successive individualmaterial sheets being fed into the press, as described hereinbefore.

In a variation of the manufacturing method shown in FIG. 47, FIG. 55shows material laminate 40, having pairs of resilient layer strandscombined therein. The strands diverge laterally in a continuousrepeating pattern and are laterally spaced across the width of materiallaminate 40. Die cut lines 52 form rows of device peripheries, such thattwo rows of peripheries are formed substantially on a common die cutline: the upper long edges of the peripheries of one row on a commonline with the upper long edges of peripheries of the adjacent row. Eachtwo rows of peripheries align with, and correspond to, two pairs ofresilient layer strands. Of necessity, each two rows of peripheries arespaced from the paired rows adjacent thereto, since the deviceperipheries are configured so as to form only the upper long edgesthereof on a common line.

FIG. 55 further illustrates the divergent segments of the strandscorresponding to the longitudinal extent of finished dilator device endregions, while a comparatively shorter longitudinal segment correspondsto the shorter intermediate region 36 (more particularly illustrated inFIG. 56). Another shorter longitudinal segment corresponds to the spacebetween successive die cut line peripheries. To facilitate common diecut lines, the truss is configured so that the long edges of twoopposing end regions of two successive dilator peripheries fit into thespace between the lateral edges of the upper tab extensions, and theupper long edge of the truss between the tab extensions, of the adjacentperiphery. FIG. 56 more particularly illustrates the finished device,where the truss is symmetric on both sides of lateral centerline b, andeach end region, by itself, is symmetric on each side of itslongitudinal centerline a.

FIG. 57 illustrates a variation of the manufacturing method shown inFIG. 50a . Resilient layer strands 26 have both straight and curvedsegments, the former corresponding to finished dilator end regions andthe latter corresponding to the intermediate region. Resilient layerstrand 26 curves laterally from a horizontal segment to form acomparatively short radial protrusion, then curves laterally in thereverse direction back to a longitudinally straight segment. Straightsegments also correspond the space between successive dilatorperipheries formed by die cut lines 52. Adjacent groups 29 each comprisethree laterally contiguous resilient layer strands 26. As describedhereinbefore, the widths of group 29 and device peripheries are eachconfigured to suitable design parameters and so that one strand 26 fromeach consecutive group 29 aligns with each row of die cut lineperipheries.

Die cut lines 52 form dilator peripheries having identical opposing longedges, which also conform to the long edges of strands 26. Finisheddevices are die cut entirely on common longitudinal lines. Accordingly,the finished device does not have end edge elements such as tabextensions or material separations. Rather, the long edges of the trussextend from one end region through the intermediate region to oppositeend region on an unbroken line. Similarly, the truss end edges extend ina straight line from the upper outside corner to the lower outsidecorner thereof. Dashed lines illustrate that material laminate 40 may bebisected between successive finished devices to segment and encapsulatefinished devices between packaging webs, as illustrated previously withrespect to FIGS. 9e and 10.

As illustrated and described in examples of the preferred embodiments,the present invention provides methods of manufacturing medical devices,particularly devices for dilating external tissue, including a widerange of diverse and complex nasal dilator devices.

I claim:
 1. A nasal dilator comprising: an engagement element comprisingat least one of a base member or a cover member; a functional elementcomprising at least two discrete, adjacent, spaced apart, substantiallyparallel resilient members having uniform width extending betweenterminal ends thereof, the resilient members having mid-sectionssubstantially parallel to a longitudinal centerline of the nasaldilator, wherein at least one of the at least two substantially parallelresilient members includes lateral end portions that diverge obliquelyaway from the longitudinal centerline of the nasal dilator and toward anearest long edge of the nasal dilator.
 2. The dilator of claim 1wherein a first resilient member of the at least two resilient membersextends from end to end in a straight line, a second resilient member ofthe at least two resilient members has opposite end portions thatdiverge obliquely away from the longitudinal centerline toward a nearestlong edge of the nasal dilator; and wherein a plan view periphery of thenasal dilator is symmetric about a lateral centerline of the nasaldilator and asymmetric about the longitudinal centerline thereof.
 3. Thedilator of claim 1 wherein at least a different one of the at least twosubstantially parallel resilient members includes lateral end portionsthat diverge obliquely away from the longitudinal centerline of thenasal dilator and toward a different nearest long edge of the nasaldilator, the dilator further comprising: a third resilient memberextending from end to end in a straight line, said third resilientmember positioned between the at least two substantially parallelresilient members and parallel to the longitudinal centerline.
 4. Thedilator of claim 1 wherein: the engagement element comprises a basemember having a first peripheral shape and a cover member having asecond peripheral shape; the functional element comprising at least twosubstantially parallel resilient members forms a third peripheral shape;and wherein each of the peripheral shapes are different from each other,such that the cover member has a greatest surface area, the base memberhas a lesser surface area than the cover member, and a total surfacearea of all of the at least two substantially parallel resilient membersis less than or equal to the lesser surface area of the base member. 5.The dilator of claim 1 wherein all of the resilient members haveopposite end portions that diverge obliquely in a common directiontoward a same long edge of the nasal dilator; and wherein a plan viewperiphery of the nasal dilator is symmetric about a lateral centerlineof the nasal dilator and asymmetric about the longitudinal centerlinethereof.
 6. The dilator of claim 1 wherein the lateral end portions ofthe second resilient member are longer than a mid portion thereof. 7.The dilator of claim 1 wherein at least one resilient member has a firstlength, a first width, and a first thickness, and at least one otherresilient member has a thickness exceeding the first thickness, a widthat least equal to the first width, and a length at least equal to thefirst length.
 8. The dilator of claim 1 wherein the engagement elementcomprises a thin, supple plastic film, and the at least two resilientmembers of the functional element are secured to a flat surface sidethereof.
 9. The nasal dilator of claim 1, further comprising aprotective release liner having a periphery extending outboard at leasta portion of the nasal dilator periphery, the release liner peripheryincluding a lip thereat for grasping by a user preliminary to using thedilator.
 10. A nasal dilator comprising a laminate of vertically stackedmaterial layers, including: a base layer comprising a base member havinga first peripheral shape; a resilient layer comprising at least oneresilient member having a second peripheral shape; a cover layercomprising a cover member having a third peripheral shape; and whereineach of the peripheral shapes are different from each other, such thatthe cover member has a greatest surface area, the base member has alesser surface area than the cover member, and the at least oneresilient member has a lesser surface area than the base member.
 11. Thenasal dilator of claim 10, wherein the resilient layer comprises fromone to six discrete, laterally adjacent, spaced apart, substantiallyparallel resilient members.
 12. A nasal dilator comprising: anengagement layer comprising at least one of a base member or a covermember; and at least one oblong resilient member having roughly parallellong edges and a longitudinal resilient member centerline therebetween,wherein the longitudinal resilient member centerline includes curvesbending both left and right.
 13. The nasal dilator of claim 12, whereinthe at least one oblong resilient member whose longitudinal resilientmember centerline has curves bending both left and right, forms a shapethat is symmetric about a lateral centerline of the dilator, such that ashape of the oblong resilient member on one side of the lateralcenterline is a mirror image of a shape of the oblong resilient memberon another side of the lateral centerline.